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OpenTrials
Completed

NCT Number: NCT01975142

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

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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Key information

Conditions

Metastatic Breast Cancer, HER2 Negative Primary Tumor Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinique Victor Hugo, Le Mans, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Trastuzumab - Emtansine

Drug

Primary outcomes

  1. Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells

    Time frame: Until disease progression (estimated duration : 1 year)

    Assessment every 6 weeks.

Secondary outcomes

  1. Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics

    Time frame: 1 month

  2. Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells

    Time frame: 1 month

  3. Correlation between HER2 FISH and immunofluorescence on circulating tumor cells

    Time frame: 1 month

  4. Progression-free survival

    Time frame: 4 years

  5. Disease control rate (responses and stable diseases)

    Time frame: Until disease progression (estimated duration : 1 year)

  6. Correlation between treatment efficacy and HER2 FISH results (level of amplification, absolute number and percentage of amplified cells)

    Time frame: Until disease progression (estimated duration : 1 year)

  7. Changes in CTC numbers during treatment

    Time frame: Until disease progression (estimated duration : 1 year)

  8. Circulating tumor DNA before and during treatment

    Time frame: Until disease progression (estimated duration : 1 year)

  9. Treatment toxicity

    Time frame: Until disease progression (estimated duration : 1 year)

    Toxicity of the treatment from first intake until disease progression

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Nov 4, 2013
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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