Metastatic Breast Cancer, HER2 Negative Primary TumorPhase 2NCT01975142
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
A Phase 2 study testing Trastuzumab - Emtansine in people with Metastatic Breast Cancer, HER2 Negative Primary Tumor, run by Institut Curie at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, HER2 Negative Primary Tumor
- What is being tested?
- Trastuzumab - Emtansine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 10 sitesFrance
- Study dates
- 7 Nov 2013to 21 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Clinique Victor Hugo
Le Mans, 72000
Institut de Cancérologie HARTMANN
Levallois-Perret, 92309
Centre Oscar Lambret
Lille, 59020
Chu de Limoges
Limoges, 87042
Centre Val d'Aurelle - P. Lamarque
Montpellier, 34298
Institut Curie
Paris, 75005
Chu Saint-Louis
Paris, 75475
Institut Curie - Hôpital René HUGENIN
Saint-Cloud, SAINT-CLOUD
Centre Catherine de Sienne
Vandœuvre-lès-Nancy, 54519
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
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.
- Being tested
- Trastuzumab - Emtansine
- Keywords
- Metastatic breast cancer, HER2 negative primary tumor, CTC HER2 positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab - EmtansineDrug
| Study group | Role | What they receive |
|---|---|---|
| TDM-1 | Experimental | Not described Receives: Drug: Trastuzumab - Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells
Assessment every 6 weeks.
Measured: 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
Measured: 1 month
Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells
Measured: 1 month
Correlation between HER2 FISH and immunofluorescence on circulating tumor cells
Measured: 1 month
Progression-free survival
Measured: 4 years
Disease control rate (responses and stable diseases)
Measured: 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)
Measured: Until disease progression (estimated duration : 1 year)
Changes in CTC numbers during treatment
Measured: Until disease progression (estimated duration : 1 year)
Circulating tumor DNA before and during treatment
Measured: Until disease progression (estimated duration : 1 year)
Treatment toxicity
Toxicity of the treatment from first intake until disease progression
Measured: Until disease progression (estimated duration : 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study start7 Nov 2013
- Primary completion13 Feb 2018
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast Cancer, HER2 Negative Primary TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975142
- Sponsor's protocol ID
- IC 2013-03
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2013
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31727113
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
- ClinicalTrials.gov ID
- NCT01975142
- Acronym / sponsor ID
- IC 2013-03
- Keywords
- Metastatic breast cancer, HER2 negative primary tumor, CTC HER2 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 7 Nov 2013 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDM-1 | Experimental | Drug: Trastuzumab - Emtansine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab - Emtansine | Drug | TDM-1 |
Primary outcome
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.
9 secondary outcomes
Detection rate of HER2 amplified circulating tumor cells, heterogeneity rate between circulating tumor cells and correlations with patient characteristics
Time frame: 1 month
Technical failure rate and reproducibility of HER2 FISH on circulating tumor cells
Time frame: 1 month
Correlation between HER2 FISH and immunofluorescence on circulating tumor cells
Time frame: 1 month
Progression-free survival
Time frame: 4 years
Disease control rate (responses and stable diseases)
Time frame: 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)
Time frame: Until disease progression (estimated duration : 1 year)
Changes in CTC numbers during treatment
Time frame: Until disease progression (estimated duration : 1 year)
Circulating tumor DNA before and during treatment
Time frame: Until disease progression (estimated duration : 1 year)
Treatment toxicity
Time frame: Until disease progression (estimated duration : 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 31727113Jacot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab - Emtansine in people with Metastatic Breast Cancer, HER2 Negative Primary Tumor, run by Institut Curie at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate to T-DM1 in patients with HER2 amplified circulating tumor cells (time frame: Until disease progression (estimated duration : 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.