- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214381
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response
March 23, 2023 updated by: West German Study Group
A Prospective, Multicenter, Open-label Comparison of Pre-surgical Myocet/ Cyclophosphamide (MC) q3w Followed by Either MC or Paclitaxel - Depending on Early Response Assessment by Ultrasound or by Toxicity for Elderly Non Frail Primary Breast Cancer Patients With Increased Risk of Relapse.
Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 3
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
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Moenchengladbach, Germany, 41061
- Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
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Munich, Germany, 81337
- Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
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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
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
General Inclusion Criteria for ADAPT:
- Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- Candidate for chemotherapy on the basis of conventional criteria
- Histologically confirmed unilateral primary invasive carcinoma of the breast
- Clinical T1 - T4a-c
- All clinical N (cN)
- No clinical evidence for distant metastasis (M0)
- Known HR status and HER2 status (local pathology)
- Tumor block available for central pathology review
- Performance Status ECOG <= 1 or KI >= 80%
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- The patient must be accessible for treatment and follow-up
- Patients must qualify for neoadjuvant treatment
LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to chemotherapy)
Laboratory requirements :
- Leucocytes ≥ 3.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 10 g/dL
- Total bilirubin ≤ 1 x ULN
- ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x UNL
- Creatinine ≤ 175 µmol/L (2 mg/dl)
Additional inclusion criteria ADAPT Elderly:
- ≥ 70 years old
- Charlson scale ≤ 2
- HR+/HER2- disease: if RS and sequential testing are available N0-1/RS 12-25/poor response or N0-1/RS ≥26
- All G3 with Ki-67 ≥40% in tumors >1cm
- All N2
- All TN
- All subtypes
General Exclusion Criteria for ADAPT:
- Known hypersensitivity reaction to the compounds or incorporated substances
- Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- Non-operable breast cancer including inflammatory breast cancer
- Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry (concurrent participation in non-interventional post authorization safety studies not influencing the primary study endpoints is allowed, e.g. WSG PROTROCA for evaluation of primary/secondary G-CSF prophylaxis)
- Male breast cancer
- Sequential breast cancer
- Reasons indicating risk of poor compliance
- Patient not able to consent
Additional Exclusion Criteria ADAPT Elderly:
- Known polyneuropathy ≥ grade 2
- Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
- Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
- Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 12 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
- Severe dyspnea
- Pneumonitis
- Abnormal blood values:
- Thrombocytopenia > CTCAE grade 1
- Increases in ALT/AST > CTCAE grade 1
- Hypokalaemia > CTCAE grade 1
- Neutropenia > CTCAE grade 1
- Anaemia > CTCAE grade 1
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mycet/Cyclophosphamid
4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
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Other Names:
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Active Comparator: Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
Time Frame: After 5 years of follow-up.
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After 5 years of follow-up.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.
Time Frame: After 5 years of follow-up.
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After 5 years of follow-up.
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Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events.
Time Frame: After 5 years of follow-up.
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After 5 years of follow-up.
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Number of pCR in non-responders to MC.
Time Frame: After 5 years of follow-up.
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After 5 years of follow-up.
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G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle
Time Frame: After 5 years of follow-up.
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After 5 years of follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
July 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
July 31, 2014
First Submitted That Met QC Criteria
August 7, 2014
First Posted (Estimate)
August 12, 2014
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Paclitaxel
- Doxorubicin
Other Study ID Numbers
- WSG-AM06 / ADAPT Elderly
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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