To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) (TOUCH)

December 10, 2024 updated by: ETOP IBCSG Partners Foundation

Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TOUCH is an open label, international, phase II neoadjuvant trial which will assess the treatment of elderly patients with hormone receptor positive / human epidermal growth factor receptor-2 (HER2) positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

The neo-adjuvant setting was chosen to evaluate these therapy combinations in a short time-frame and to provide access to biomaterial both at baseline and after the end of the treatment, at surgery. Biopsy specimens will be analyzed at the end of the trial by gene-expression profiling to assess RBsig status. This marker may represent a tool to identify the participants who are more likely to benefit from a chemotherapy-free regimen in this population.

Palbociclib is a potent, highly selective, reversible, orally active, inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4/6), therefore inhibiting cell growth and can be safely and effectively administered to older patients without need for dose adjustment based solely on age. Treatment de-escalation, namely harnessing and taking maximum advantage of targeted therapies vs conventional treatment (chemotherapy) in order to limit side effects, is particularly appealing in the older population.

Clinical data from the HR positive /HER2 negative setting show that combinations of palbociclib and letrozole are safe and effective. These combinations have not yet been tested in the HR positive /HER2 positive population that the investigators include in this trial. However, combinations of trastuzumab and endocrine treatment (ET), including letrozole have shown to be safe and to have some additional activity compared to ET alone in the HR positive /HER2 positive population. Therefore, the role of palbociclib in addition to letrozole and trastuzumab plus pertuzumab needs to be further studied.

Current standard of care for treatment of HER2 positive BC incorporates chemotherapy and anti-HER2 agents, with chemotherapy regimens of sequential anthracyclines and taxanes, used as single agents or in combination with other chemotherapy drugs. Trastuzumab is often administered concurrently with a single agent taxane to avoid the possible additive cardiac toxicity of combinations of anthracycline containing regimens and trastuzumab.

A regimen of weekly paclitaxel and trastuzumab plus pertuzumab was chosen as the comparator arm in this trial. More aggressive chemotherapy may not be justified in this population and trial participants may receive additional treatment after surgery, at the discretion of the treating doctor.

Preclinical and clinical rationale exists to support the proposal that palbociclib may represent a valuable option for increasing the activity of ET and anti-HER2 agents, such that a triple combination with these agents could prove superior to a standard treatment with chemotherapy and anti-HER2 agents.

The investigators hypothesize that the combination of palbociclib, letrozole and trastuzumab plus pertuzumab proposed in this trial will be more efficacious compared to the combinations of anti-HER2 agents and ET reported in other trials.

In 2019, it is estimated that of 260,600 newly diagnosed cases of invasive breast cancer in the United States, 82% occurred in women aged 50 or over. Furthermore, of the 41,760 breast cancer-related deaths in the same year, 90% occurred in this predominantly post-menopausal age group. Around 40% of BCs occur in women aged 65 and older. Of these, 10-15% have tumors that overexpress HER2. Elderly patients are generally underrepresented in clinical trials and may benefit from anti-HER2 agents as much as the younger population. Post-menopausal patients with HR positive /HER2 positive BC represent a unique group of patients with an unmet clinical need. This population is the focus of the TOUCH trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina, Augustijinslei 100
      • Brussels, Belgium, 1000
        • Jules Bordet Institute
      • Liège, Belgium, 4000
        • CHR de la Citadelle, Boulevard du XIIe de Ligne, 1
      • Liège, Belgium, 4000
        • Clinique Saint- Joseph, Rue de Hesbaye 75
      • Namur, Belgium, 5000
        • Clinique Saint Elizabeth, Place Louise Godin 15
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas, Moerlandstrat 1
  • France
      • Avignon, France
        • Institut Sainte Catherine
      • Bordeaux, France
        • Institut Bergonié
      • Le Mans, France
        • Centre Hospitalier Le Mans
      • Lyon, France
        • Centre Leon Berard
      • Montpellier, France
        • Icm Val D'Aurelle
      • Nantes, France
        • Institut de Cancérologie de l'Ouest (ICO)
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Paris, France
        • Institut Curie - Site de Paris
      • Pringy, France
        • Centre Hospitalier Annecy Genevois
      • Rennes, France
        • Centre Eugène Marquis
      • Rouen, France
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92210
        • Institut Curie - Site Saint Cloud
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • Clinique Pasteur
  • Italy
      • Alessandria, Italy, 15121
        • ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16
      • Bergamo, Italy, 24127
        • Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1
      • Bologna, Italy, 40138
        • Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2
      • Bolzano, Italy, 39100
        • Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5
      • Brescia, Italy, 25123
        • ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1
      • Genova, Italy, 16128
        • E.O. Ospedali Galliera, Mura delle Cappuccine, 14
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino,Largo Rosanna Benzi,10
      • Lecco, Italy, 23900
        • Ospedale Civile di Lecco,Via della Filanda 14
      • Milano, Italy, 20141
        • Milano, IEO, Via Ripamonti 435
      • Novara, Italy, 28100
        • Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18
      • Parma, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14
      • Pavia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10
      • Pisa, Italy, 56125
        • A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67
      • Prato, Italy, 59100
        • Hospital of Prato, Via Dolce dei Mazzamuti, 7
      • Ravenna, Italy, 48121
        • Santa Maria delle Croci Hospital, Viale Randi 5
      • Rimini, Italy, 47037
        • UO Oncologia, Rimini Hospital, Via Settembrini 2
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15
      • Varese, Italy, 21100
        • AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57
    • Ancona
      • Torrette, Ancona, Italy, 60020
        • Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,
    • Forli
      • Meldola, Forli, Italy, 47014
        • Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40
    • Modena
      • Carpi, Modena, Italy, 41012
        • U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2
  • Switzerland
      • Bern, Switzerland
        • Inselspital Bern
      • Freiburg, Switzerland, 1708
        • HFR Freiburg - Kantonsspital
      • Geneva, Switzerland
        • University Hospital Geneva
      • Saint Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen, Rorschacher Strasse 95
      • Zurich, Switzerland, 8008
        • Brust-Zentrum AG, Seefeldstrasse 214
    • Aarau
      • Baden, Aarau, Switzerland, 5400
        • Kantonsspital Baden AG
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitatsspital Basel, Petersgraben 4
    • Thurgau
      • Frauenfeld, Thurgau, Switzerland, 8501
        • Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
        • Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • University Hospital Zurich, Frauenklinikstrasse 10
    • Zürich
      • Winterthur, Zürich, Switzerland, 8401
        • Kantonsspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed invasive breast cancer, with the following characteristics:

    • Early breast cancer with tumor size >1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography);
    • No clinical evidence of regional lymph node metastasis (via physical and/or radiological exam) (cN0) OR
    • Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s)
    • No evidence of metastasis (M0).

  2. Postmenopausal, defined by women with:

    • Prior bilateral surgical oophorectomy; OR
    • Amenorrhea and age ≥60 years; OR
    • Age <60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, ovarian suppression, or hormonally-based contraception) plus FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. Primary tumor must have positive estrogen receptor (ER) ≥10%
  5. Primary tumor must be HER2-positive (by IHC and/or ISH)
  6. Baseline LVEF ≥55% measured by Echocardiography (preferred) or MUGA scan

  7. Normal hematologic status:

    • Absolute neutrophil count ≥1500/mm3 (1.5 × 109/L);
    • Platelets ≥100 × 109/L;
    • Hemoglobin ≥9 g/dL (≥90 g/L).
  8. Normal renal function: serum creatinine ≤1.5 ULN

  9. Normal liver function:

    • Serum total bilirubin ≤1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 × ULN) is allowed;
    • AST or ALT ≤2.5 × ULN;
    • Alkaline phosphatase ≤2.5 × ULN.
  10. Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
  11. The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  12. The patient agrees in writing to make tumor (mandatory diagnostic core biopsy and surgical specimen) available for submission for central pathology review and to conduct translational studies as part of this protocol.

Exclusion Criteria:

  1. Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) (T4 according to AJCC 8th edition cancer staging TNM)
  2. Inflammatory breast cancer
  3. Bilateral invasive breast cancer
  4. Received any prior treatment for primary invasive breast cancer
  5. Any active tumor of non-breast-cancer histology
  6. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification ≥II), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  7. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
  8. Contraindications or known hypersensitivity to any of the trial medications or excipients
  9. Treatment with any investigational agents within 30 days prior to expected start of trial treatment
  10. Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection
  11. Evidence via physical and/or radiological exam of cN2 or cN3 nodal involvement defined by: metastasis to ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted, OR involvement of ipsilateral infraclavicular, internal mammary and/or supraclavicular lymph node(s)
  12. History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Paclitaxel plus trastuzumab and pertuzumab
Receiving paclitaxel 80mg/m2 i.v. on day 1, 8, 15 every 28 days for 4 cycles, trastuzumab 600mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for a total of 5 doses.
Drug: Paclitaxel
Chemotherapy plus HER2 Blockade
Other Names:
  • Paclitaxel Sandoz
Drug: Trastuzumab
Chemotherapy plus HER2 Blockade
Other Names:
  • Herceptin
Drug: Pertuzumab
Chemotherapy plus HER2 Blockade
Other Names:
  • Perjeta
Drug: Trastuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Herceptin
Drug: Pertuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Perjeta
Experimental: Palbociclib plus letrozole plus trastuzumab and pertuzumab
Receiving palbociclib 125 mg/day orally for 21 days followed by 7 day's rest, for four 28 day cycles, letrozole 2.5 mg/day orally for 16 weeks and trastuzumab 600 mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for 5 doses.
Drug: Trastuzumab
Chemotherapy plus HER2 Blockade
Other Names:
  • Herceptin
Drug: Pertuzumab
Chemotherapy plus HER2 Blockade
Other Names:
  • Perjeta
Drug: Trastuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Herceptin
Drug: Pertuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Perjeta
Drug: Palbociclib
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Ibrance
Drug: Letrozole
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR)
Time Frame: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Pathological complete response (pCR) is defined as absence of invasive tumour cells in the breast and in the axillary lymph nodes at the time of surgery (ypT0/ypTis ypN0) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual. The presence of in situ cancer after trial treatment in the absence of residual invasive disease constitutes a pCR.
Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) in the Breast
Time Frame: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Defined as the absence of invasive tumour cells in the breast at the time of surgery (ypT0/ypTis) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual..
Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Objective Response
Time Frame: Tumor assessments were performed by ultrasound and mammography at screening (prior to treatment start), and before surgery; measurements by caliper were assessed at the same time points and at the end of cycle 2 (28 days/cycle), approximately 56 days.

The number of patients with partial or complete response measured physically by caliper and by ultrasound and mammography. Response was assessed using World Health Organization tumor measurement and response criteria.

Complete response (CR) - The disappearance of all known disease. Partial response (PR) - A 50% or more decrease in total tumor size, i.e., the sum of the products of the maximal diameter (MD) and the corresponding largest perpendicular diameter (LPD) of the lesions which have been measured to determine the effect of therapy. In addition, there can be no appearance of new lesions or progression of any lesion.

Stable disease (SD) - Neither a 50% decrease in total tumor size, nor a 25% increase in the size of one or more measurable lesions has been determined.

Progressive disease (PD) - An increase of least 25% in total tumor size relative to the smallest size measured during the trial.
Tumor assessments were performed by ultrasound and mammography at screening (prior to treatment start), and before surgery; measurements by caliper were assessed at the same time points and at the end of cycle 2 (28 days/cycle), approximately 56 days.
Rate of Breast Conserving Surgery (BCS)
Time Frame: From randomization until completion of study, up to 20 months
Defined as the number of patients undergoing BCS, divided by the number of patients in the assessable population (subset of the randomized population with RBsig status successfully determined who received at least 1 dose of medication).
From randomization until completion of study, up to 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ETOP IBCSG Partners Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Laura Biganzoli, MD, USL4 Hospital of Prato, Italy
  • Study Chair: Etienne Brain, MD, Institut Curie, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBCSG 55-17
  • 2017-005067-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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