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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-07

Study Completion Date

2019-01-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer, HER2 Negative Primary Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TDM-1

Group Type EXPERIMENTAL

Trastuzumab - Emtansine

Intervention Type DRUG

Interventions

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Trastuzumab - Emtansine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No