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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975142
Recruitment Status : Completed
First Posted : November 3, 2013
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer, HER2 Negative Primary Tumor Drug: Trastuzumab - Emtansine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
Actual Study Start Date : November 7, 2013
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : January 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TDM-1 Drug: Trastuzumab - Emtansine



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975142


Locations
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France
Clinique Victor Hugo
Le Mans, France, 72000
Institut de Cancérologie HARTMANN
Levallois-perret, France, 92309
Centre Oscar Lambret
Lille, France, 59020
Chu de Limoges
Limoges, France, 87042
Centre Val d'Aurelle - P. Lamarque
Montpellier, France, 34298
Institut Curie
Paris, France, 75005
Chu Saint-Louis
Paris, France, 75475
Institut Curie - Hôpital René HUGENIN
Saint-cloud, France, SAINT-CLOUD
Centre Catherine de Sienne
Vandoeuvre Les Nancy, France, 54519
Institut de Cancérologie de Lorraine
Vandoeuvre Les Nancy, France, 54519
Sponsors and Collaborators
Institut Curie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01975142    
Other Study ID Numbers: IC 2013-03
First Posted: November 3, 2013    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Curie:
Metastatic breast cancer
HER2 negative primary tumor
CTC HER2 positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Trastuzumab
Ado-trastuzumab emtansine
Maytansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action