NCT01975142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

November 7, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

4.3 years

First QC Date

October 17, 2013

Last Update Submit

November 19, 2025

Conditions

Metastatic Breast Cancer, HER2 Negative Primary Tumor

Keywords

Metastatic breast cancerHER2 negative primary tumorCTC HER2 positive

Outcome Measures

Primary Outcomes (1)

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

    Assessment every 6 weeks.

    Until disease progression (estimated duration : 1 year)

Secondary Outcomes (9)

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

    1 month

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

    1 month

  • Correlation between HER2 FISH and immunofluorescence on circulating tumor cells

    1 month

  • Progression-free survival

    4 years

  • Disease control rate (responses and stable diseases)

    Until disease progression (estimated duration : 1 year)

  • +4 more secondary outcomes

Study Arms (1)

TDM-1

EXPERIMENTAL
Drug: Trastuzumab - Emtansine

Interventions

Trastuzumab - EmtansineDRUG
TDM-1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Clinique Victor Hugo

Le Mans, 72000, France

Location

Institut de Cancérologie HARTMANN

Levallois-Perret, 92309, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Chu de Limoges

Limoges, 87042, France

Location

Centre Val d'Aurelle - P. Lamarque

Montpellier, 34298, France

Location

Institut Curie

Paris, 75005, France

Location

Chu Saint-Louis

Paris, 75475, France

Location

Institut Curie - Hôpital René HUGENIN

Saint-Cloud, SAINT-CLOUD, France

Location

Centre Catherine de Sienne

Vandœuvre-lès-Nancy, 54519, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • Jacot W, Cottu P, Berger F, Dubot C, Venat-Bouvet L, Lortholary A, Bourgeois H, Bollet M, Servent V, Luporsi E, Espie M, Guiu S, D'Hondt V, Dieras V, Sablin MP, Brain E, Neffati S, Pierga JY, Bidard FC. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019 Nov 14;21(1):121. doi: 10.1186/s13058-019-1215-z.

    PMID: 31727113BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MaytansineMacrolidesLactonesOrganic ChemicalsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsTrastuzumabAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

November 4, 2013

Study Start

November 7, 2013

Primary Completion

February 13, 2018

Study Completion

January 21, 2019

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)