- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835236
Trastuzumab & Pertuzumab Followed by T-DM1 in MBC
A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
-To evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inhibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line) and of a chemotherapy-containing dual HER2-inhibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line) in patients with HER2-positive metastatic breast cancer.
Secondary
- To evaluate other efficacy parameter
- To evaluate the safety and tolerability profile of the two treatment strategies
- To evaluate the Quality of Life (QoL)
- To learn how patients are treated after trial treatment
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor status (positive vs negative), prior trastuzumab (never or >12 months vs ≤12 months after last infusion), visceral metastases (present vs absent) and site. Patients are randomized to 1 of 2 treatment arms.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Amiens, France, 80054
- Hopital Sud - Amiens
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Angers, France, 49933
- ICO - Paul Papin
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Avignon Cedex 9, France, 84918
- Institut Sainte Catherine
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Blois, France, 41016
- Centre Hospitalier de Blois
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Bordeaux, France, 33076
- Institut Bergonie
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Brest, France, 29200
- Hôpital Morvan (Brest)
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Caen, France, 14076
- Centre François Baclesse
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Contamine-Sur-Arve, France, 74130
- Centre Hospitalier Alpes Léman
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Dijon Cedex, France, 21079
- Centre Georges François Leclerc
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Draguignan, France, 83007
- Centre Hospitalier de Dracenie
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Grenoble, France, 38043
- Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
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Levallois-Perret, France, 92300
- Clinique Hartmann
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Lille, France, 59020
- Centre Oscar Lambret
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Limoges, France, 87042
- CHU de Limoges - Hôpital Dupuytren
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Lorient Cedex, France, 56322
- Centre Hospitalier - Site Hopital du Scorff
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Lyon, France, 69009
- Clinique de la Sauvegarde
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Marseille, France, 13003
- Fondation Hopital Ambroise Pare - Hopital Europeen
-
Marseille, France, 13273
- Istitut Paoli Calmettes
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Montpellier, France, 34298
- Institut Régional du Cancer Montpellier Val d'Aurelle
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Mougins, France, 6250
- Centre Azuréen de Cancérologie
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Nancy, France, 54100
- Polyclinique de Gentilly
-
Nantes, France, 44202
- Centre Catherine De Sienne
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Nice Cedex 2, France, 6189
- Centre Antoine Lacassagne
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Paris, France, 75475
- Hôpital Saint Louis
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Pau, France, 64046
- Centre Hospitalier de Pau
-
Perpignan, France, 66046
- Centre Hospitalier de Perpignan - Hopital Saint Jean
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Reims, France, 51726
- Institut Jean Godinot
-
Rouen, France, 76038
- Centre Henri Becquerel
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Rouen, France, 76000
- Clinique Mathilde
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Saint Herblain, France, 44805
- ICO - Rene Gauducheau
-
Saint-Cloud, France, 92210
- Curie Site Saint-Cloud
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Saint-Priest-En-Jarez, France, 42271
- Institut de Cancerologie de la Loire
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Strasbourg, France, 67091
- Hopitaux Universitaire de Strasbourg - Hopital Civil
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Thonon Les Bains, France, 74203
- Hopitaux Du Leman - Site Georges Pianta
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Toulouse Cedex 9, France, 31059
- Institut Claudius Regaud
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Valence Cedex 9, France, 26953
- Centre Hospitalier de Valence
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Ulm, Germany, 89075
- Universitäts-Frauenklinik Ulm
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Almelo, Netherlands, 7609 PP
- Almelo_Ziekenhuisgroep Twente
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Amsterdam, Netherlands, 1007
- VUmc University Medical Center
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Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoek / Slotervaart hospital
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Delft, Netherlands, 2625 AD
- Reinier de Graaf Gasthuis
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Den Haag, Netherlands, 2545 CH
- Haga Ziekenhuis
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Deventer, Netherlands, 7416 SE
- Deventer Ziekenhuis
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Eindhoven, Netherlands, 5623 EJ
- Catharina Ziekenhuis
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Leeuwarden, Netherlands, 8934 AD
- Medisch Centrum Leeuwarden
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Leiden, Netherlands, 2333 ZA
- Leiden_Leids Universitair Medisch Centrum (LUMC)
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Nieuwegein, Netherlands, 3430 EM
- St. Antonius Ziekenhuis, Ioc Nieuwegein
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Rotterdam, Netherlands, 3045 PM
- St. Franciscus Gasthuis Rotterdam
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Schiedam, Netherlands, 3118 JH
- Vlietland Ziekenhuis
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Sittard, Netherlands, 6162 BG
- Orbis Medisch Centrum
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Aarau, Switzerland, CH-5001
- Hirslanden Klinik Aarau
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Aarau, Switzerland, CH-5001
- Kantonspital Aarau
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Baden, Switzerland, 5404
- Kantonsspital Baden
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Basel, Switzerland, 4031
- Universitaetsspital-Basel
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Bellinzona, Switzerland, 6500
- Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
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Bern, Switzerland, CH-3010
- Inselspital, Bern
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Brig, Switzerland, 3900
- Spitalzentrum Oberwallis
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Brig, Switzerland, 3900
- RSV-GNW Spitalzentrum Oberwallis
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Chur, Switzerland, 7000
- Kantonsspital Graubuenden
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Frauenfeld, Switzerland, 8501
- Kantonsspital Frauenfeld / Brustzentrum Thurgau
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Genève 14, Switzerland, 1211
- Hopitaux Universitaires de Geneve
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Lausanne, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Lausanne, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois CHUV
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Liestal, Switzerland, CH-4410
- Kantonsspital Liestal
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Luzerne, Switzerland, CH-6000
- Kantonsspital Luzern
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Olten, Switzerland, 4600
- Kantonsspital Olten
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St. Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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St. Gallen, Switzerland, CH-9006
- Zentrum fuer Tumordiagnostik und Praevention
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Thun, Switzerland, 3600
- SpitalSTS AG Simmental-Thun-Saanenland
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Winterthur, Switzerland, 8401
- Kantonsspital Winterthur
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Zürich, Switzerland, 8091
- Universitäts Spital Zürich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
SELECTION OF PATIENTS (MOST IMPORTANT CRITERIA)
Inclusion criteria for first-line therapy
• Histologically confirmed breast cancer with distant metastases
Note:
- A biopsy from the primary tumor or a metastasis can be used for diagnosis.
- Patients with non-measurable lesions are eligible.
- Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible.
- Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible.
Patients with de-novo Stage IV disease are eligible.
- HER2-positive tumor according to central pathology testing for HER2
Note:
- A formalin-fixed paraffin-embedded (FFPE) biopsy from the primary tumor or a metastasis has to be used for HER2 status determination. If a biopsy is available from a metastasis, the HER2 testing should be performed using the metastasis.
Fine needle aspiration is not acceptable for HER 2 testing. • Women aged ≥18 years
• WHO performance status 0 to 2
- Left Ventricular Ejection Fraction (LVEF) ≥50% as determined by either ECHO or MUGA
- Adequate organ function, evidenced by the following laboratory results:
Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin ≥90g/L, total bilirubin ≤1.5xULN (unless the patients has documented Gilbert's disease), AST ≤3xULN, ALT ≤3xULN, AP ≤2.5xULN (except in patients with bone metastases: AP ≤5xULN), creatinine ≤1.5xULN
Exclusion criteria for first-line therapy
• Prior chemotherapy for inoperable locally advanced or metastatic breast cancer
Note:
Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracyclines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively.
- Re-exposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomization.
- Re-exposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomization.
- Prior anti-HER2 treatment for metastatic or inoperable breast cancer
Note:
Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed.
• More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month
Note:
- Adjuvant endocrine treatment is not counted as one line.
Patients progressing on endocrine treatment: this specific endocrine treatment must have been stopped at least 2 weeks prior to randomization.
• Prior treatment with pertuzumab and/or T-DM1
• Known leptomeningeal or CNS metastases
Note:
A brain MRI or CT scan is mandatory in case of clinical suspicion of CNS metastases.
• Single bone metastasis treated with radiotherapy (if the bone metastasis is the only tumor lesion)
Inclusion criteria for second-line therapy • At least one dose of trial therapy in the first-line treatment phase of this trial
• • Proven disease progression on first-line therapy or radiotherapy of a bone metastasis
Notes:
First new parenchymal CNS metastases only do not count as progression requiring the initiation of second line trial treatment. Radiotherapy of a single area only for pain control is allowed and will not count as PD.
• Adequate organ function, evidenced by the following laboratory results: Neutrophils >1.5x109/L, platelets >100x109/L, hemoglobin ≥90g/L, total bilirubin ≤1.5xULN (unless the patients has documented Gilbert's disease), AST ≤3xULN, AP ≤2.5xULN (except in patients with bone metastases: AP ≤5xULN), creatinine ≤1.5ULN
• LVEF ≥50% as determined by either ECHO or MUGA
• QoL questionnaire has been completed.
Exclusion criteria for second-line therapy
• Termination of first-line therapy with trastuzumab/pertuzumab due to unacceptable toxicity without objective evidence of disease progression
• CNS metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from CNS metastases within 2 months (60 days) before registration
• Peripheral neuropathy of CTCAE grade ≥3
- Interstitial lung disease (ILD) or pneumonitis grade ≥3
- Any other adverse event which has not recovered to CTCAE grade ≤1 (except alopecia)
Study Plan
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 |
Intervention / Treatment |
---|---|
Active Comparator: Trastuzumab, Pertuzumab, T-DM1
First line therapy: Trastuzumab, Pertuzumab Second line therapy: T-DM1
|
First administration (loading dose) 8 mg/kg i.v. infusion over 90 min. - then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min.
Other Names:
First administration (loading dose) 840 mg i.v. infusion over 60 min. - then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min.
Other Names:
Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v.
infusion First dose: over 90 min (± 10 min.)
Subsequent doses: over 30 min.
(± 10 min.)
Other Names:
|
Active Comparator: Trastuzumab, Pertuzumab, Paclitaxel or Vinorelbine plus T-DM1
First line therapy: Trastuzumab, Pertuzumab, Paclitaxel or Vinorelbine Second line therapy: T-DM1
|
First administration (loading dose) 8 mg/kg i.v. infusion over 90 min. - then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min.
Other Names:
First administration (loading dose) 840 mg i.v. infusion over 60 min. - then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min.
Other Names:
Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v.
infusion First dose: over 90 min (± 10 min.)
Subsequent doses: over 30 min.
(± 10 min.)
Other Names:
Day 1, 8 and 15; every 4 weeks for ≥4 months 90 mg/m2 i.v.
infusion
Other Names:
First administration: Day 1 and 8 25 mg/m2 i.v. infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS) - Analysis Population: ITT Population 1
Time Frame: 24 months
|
Patients being alive 24 months after randomization.
A success is considered if a patient is alive at least 24 months after randomization.
Analysis Population: ITT Population 1
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS - Analysis Population: ITT Population 2
Time Frame: 24 months
|
Proportion of patients being alive 24 months after randomization.
A success is considered if a patient is alive at least 24 months after randomization.
Analysis Population: ITT Population 2
|
24 months
|
Progression Free Survival (PFS) of first-line treatment ignoring first Central Nervous System (CNS) lesion
Time Frame: 10 / 16 months (PFS will be calculated sustained from randomization until documented PD (ignoring first CNS lesion) or death, whichever occurs first during first-line treatment )
|
PFS of first-line treatment ignoring first CNS lesion is the time from randomization to first event progression. A PFS of first-line treatment ignoring first CNS lesion event is defined as (whichever occurs first):
Analysis population: ITT Population 1 |
10 / 16 months (PFS will be calculated sustained from randomization until documented PD (ignoring first CNS lesion) or death, whichever occurs first during first-line treatment )
|
PFS of second-line treatment
Time Frame: 8 months (PFS will be calculated sustained from registration of second line treatment until documented PD, PD CNS or death, whichever occurs first during second-line treatment)
|
PFS of second-line treatment is the time from registration of second-line treatment to progression. A PFS event of second-line treatment is defined as (whichever occurs first):
Analysis Population: ITT Population 2 |
8 months (PFS will be calculated sustained from registration of second line treatment until documented PD, PD CNS or death, whichever occurs first during second-line treatment)
|
PFS of second-line treatment ignoring first CNS lesion
Time Frame: 9 months (PFS will be calculated sustained from registration of second line treatment until documented PD (ignoring first CNS lesion) or death, whichever occurs first during second-line treatment)
|
PFS of second-line treatment ignoring first CNS lesion is the time from registration of second-line treatment to the first event occurs. A PFS of second-line treatment ignoring first CNS lesion event is defined as (whichever occurs first):
Analysis Population: ITT Population 2 |
9 months (PFS will be calculated sustained from registration of second line treatment until documented PD (ignoring first CNS lesion) or death, whichever occurs first during second-line treatment)
|
Time to failure of strategy (TFS) of first- plus second-line treatment
Time Frame: 18 / 24 months (TFS will be calculated sustained from randomization until documented PD, PD CNS or death, whichever occurs first before starting third-line therapy )
|
TFS of first plus second-line treatment is the time from randomization to TFS event occurs. A TFS event of first plus second-line treatment is defined as (whichever occurs first):
Analysis Population: ITT Population 1 |
18 / 24 months (TFS will be calculated sustained from randomization until documented PD, PD CNS or death, whichever occurs first before starting third-line therapy )
|
Overall survival OS
Time Frame: OS will be calculated from randomization until death (estimated median: 32 months)
|
OS will be calculated from randomization until death. Patients still alive or lost of follow up are censored at their last date known alive. Analysis Population: ITT Population 1 |
OS will be calculated from randomization until death (estimated median: 32 months)
|
Objective response (OR) of first-line treatment (based on investigator assessment)
Time Frame: 10 / 16 months (OR is defined as the best status of response CR or PR up to first progression or start of a new treatment)
|
10 / 16 months (OR is defined as the best status of response CR or PR up to first progression or start of a new treatment)
|
|
Disease control (DC) of first-line treatment (based on investigator assessment)
Time Frame: 6 months (DC is defined as CR, PR or SD for 6 months after randomization and no PD at 6 month after randomization)
|
6 months (DC is defined as CR, PR or SD for 6 months after randomization and no PD at 6 month after randomization)
|
|
OR of second-line treatment (based on investigator assessment)
Time Frame: 9 months (OR is defined as the best status of response CR or PR after registration for second-line treatment up to second progression or start of a new treatment)
|
9 months (OR is defined as the best status of response CR or PR after registration for second-line treatment up to second progression or start of a new treatment)
|
|
DC of second-line treatment (based on investigator assessment)
Time Frame: 6 months (DC is defined as the response CR, PR or SD for 6 months after registration of second-line treatment)
|
6 months (DC is defined as the response CR, PR or SD for 6 months after registration of second-line treatment)
|
|
Adverse events (AEs) according to the NCI CTCAE v4.0 of first-line treatment
Time Frame: Throughout first-line treatment (estimated up to 16 months)
|
Adverse events are assessed by the NCI CTCAE v4.0.
from registration until registration of second-line treatment or start of follow-up (which occurs first).
|
Throughout first-line treatment (estimated up to 16 months)
|
AEs according to the NCI CTCAE v4.0 of second-line treatment
Time Frame: Throughout second-line treatment (estimated up to 9 months)
|
Adverse events are assessed by the NCI CTCAE v4.0.from second-line registration until PD or start of follow-up (which occurs first) plus 30 days.
|
Throughout second-line treatment (estimated up to 9 months)
|
AEs grade ≥2 until first progression (ignoring first CNS lesion)
Time Frame: Throughout first-line treatment (estimated up to 16 months)
|
Adverse events are assessed by Common terminology criteria for adverse events (CTCAE) v4.0.
From randomization until first progression (documented PD, PD CNS or death)
|
Throughout first-line treatment (estimated up to 16 months)
|
Quality of Life (QoL)
Time Frame: At baseline and every 12 weeks (three-monthly) until progression or up to a maximum of 24 months during 1st line therapy. Within 3 weeks prior to registration, after 12 and 24 weeks during 2nd line therapy.
|
At baseline and every 12 weeks (three-monthly) until progression or up to a maximum of 24 months during 1st line therapy. Within 3 weeks prior to registration, after 12 and 24 weeks during 2nd line therapy.
|
|
PFS of third-line treatment
Time Frame: 4 months
|
PFS will be calculated sustained from start of third-line treatment to progression (PD, PD CNS or death)
|
4 months
|
Collaborators and Investigators
Investigators
- Study Chair: Jens Huober, MD, University of Ulm
- Study Chair: Patrik Weder, MD, Cantonal Hospital of St. Gallen
- Study Chair: Hervé Bonnefoi, Prof, Institut Bergonie Bordeaux
- Study Chair: Epie Boven, MD, Amsterdam UMC, location VUmc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Paclitaxel
- Trastuzumab
- Vinorelbine
- Ado-Trastuzumab Emtansine
- Pertuzumab
Other Study ID Numbers
- SAKK 22/10
- 2012-002556-17 (EudraCT Number)
- UNICANCER UC-0140/1207 (Other Identifier: Unicancer)
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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