Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

Phase 2

Completed

• Conditions: Metastatic Breast Cancer, HER2 Negative Primary Tumor
• Interventions: Drug: Trastuzumab - Emtansine

• Registration Number: NCT01975142
• Lead Sponsor: Institut Curie

Brief Summary

Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Study Start: 2013-11-07
• Primary Completion: 2018-02-13
• Study Completion: 2019-01-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

Inclusion criteria for screening:

• Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2
• A least one metastatic site and/or inoperable loco-regional relapse
• Measurable disease (RECIST v1.1)
• Age from 18 to 75 years
• Performance status of 0-2
• Efficient contraceptive in non-menopause women

Inclusion criteria for treatment :

• At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC
• Performance status of 0-2
• Adequate cardiac function
• Adequate hematological and biochemical blood tests

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Exclusion Criteria

• Life expectancy of less than 3 months
• Previous history of any other stage III or IV invasive cancer
• Male breast cancer
• Uncontrolled brain metastases
• Significant cumulated exposure to anthracyclines
• Current or previous significant history of cardio-vascular/pulmonary disease
• Previous use of trastuzumab

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TDM-1	Trastuzumab - Emtansine	-

Primary Outcome Measures

Name	Time	Method
Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells	Until disease progression (estimated duration : 1 year)	Assessment every 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics	1 month
Disease control rate (responses and stable diseases)	Until disease progression (estimated duration : 1 year)
Circulating tumor DNA before and during treatment	Until disease progression (estimated duration : 1 year)
Correlation between treatment efficacy and HER2 FISH results (level of amplification, absolute number and percentage of amplified cells)	Until disease progression (estimated duration : 1 year)
Correlation between HER2 FISH and immunofluorescence on circulating tumor cells	1 month
Progression-free survival	4 years
Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells	1 month
Treatment toxicity	Until disease progression (estimated duration : 1 year)	Toxicity of the treatment from first intake until disease progression
Changes in CTC numbers during treatment	Until disease progression (estimated duration : 1 year)

Trial Locations

Locations (10)

Chu de Limoges; 🇫🇷 Limoges, France

Chu Saint-Louis; 🇫🇷 Paris, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Institut Curie; 🇫🇷 Paris, France

Institut de Cancérologie HARTMANN; 🇫🇷 Levallois-perret, France

Centre Val d'Aurelle - P. Lamarque; 🇫🇷 Montpellier, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Catherine de Sienne; 🇫🇷 Vandoeuvre Les Nancy, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre Les Nancy, France

Institut Curie - Hôpital René HUGENIN; 🇫🇷 Saint-cloud, France