Breast CancerPhase 3REMAGUS04NCT01180335
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
A Phase 3 study testing Chemotherapy and Genomic driven chemotherapy in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chemotherapy and Genomic driven chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive breast cancer not eligible for conservative surgery
- Her2 negative
- Amount of tumor cells >30% on HES slides
- RIN>6 and amount of RNA>1 ug
- No metastases
- Subject, age > 18 years and <65 years old
Show all 11Show fewer
- Signed written informed consent
- PS 0-1
- No previous treatment for breast cancer
- Adequate organ function
- FEVG >50%
Who cannot join
- In situ carcinoma
- Multifocal cancers
- Her2+
- Presence of metastasis
- Genomic testing not feasible because of tumor cells <30%, RIN<6, insufficient amount of RNA
- Organ dysfunction that contraindicates chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
Read the detailed description
After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
- Conditions
- Breast Cancer
- Being tested
- Chemotherapy, Genomic driven chemotherapy
- Keywords
- Genomic driven chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
4 cycles FEC followed by 4 cycles docetaxel
Genomic driven chemotherapyDrug
High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | 4 cycles FEC followed by 4 cycles docetaxel Receives: Drug: Chemotherapy |
| Genomic driven chemotherapy | Experimental | High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine. Receives: Drug: Genomic driven chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate based on the histology
Measured: Tumoral assessment at 4 and 8 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2011
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Curie
- Responsible party
- Sponsor
- Investigators
- Florence LEREBOURS, MD, Principal investigator, Centre René HugueninJean-Yves PIERGA, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180335
- Sponsor's protocol ID
- CSET1376
- Acronym
- REMAGUS04
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2010
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamy AS, Derosa L, Valdelievre C, Yonekura S, Opolon P, Priour M, Guerin J, Pierga JY, Asselain B, De Croze D, Pinheiro A, Lae M, Talagrand LS, Laas E, Darrigues L, Grandal B, Marangoni E, Montaudon E, Kroemer G, Zitvogel L, Reyal F. Comedications influence immune infiltration and pathological response to neoadjuvant chemotherapy in breast cancer. Oncoimmunology. 2019 Nov 14;9(1):1677427. doi: 10.1080/2162402X.2019.1677427. eCollection 2020.
PubMed 32002287
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01180335
- Acronym / sponsor ID
- REMAGUS04 / CSET1376
- Conditions
- Breast Cancer
- Keywords
- Genomic driven chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Institut Curie
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Aug 2010 (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.
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
Detailed description
After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: Chemotherapy4 cycles FEC followed by 4 cycles docetaxel |
| Genomic driven chemotherapy | Experimental | Drug: Genomic driven chemotherapyHigh DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Invasive breast cancer not eligible for conservative surgery
- Her2 negative
- Amount of tumor cells >30% on HES slides
- RIN>6 and amount of RNA>1 ug
- No metastases
Key exclusion criteria (6 listed)
- In situ carcinoma
- Multifocal cancers
- Her2+
- Presence of metastasis
- Genomic testing not feasible because of tumor cells <30%, RIN<6, insufficient amount of RNA
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 |
|---|---|---|
| Chemotherapy4 cycles FEC followed by 4 cycles docetaxel | Drug | Chemotherapy |
| Genomic driven chemotherapyHigh DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine. | Drug | Genomic driven chemotherapy |
Primary outcome
Complete response rate based on the histology
Time frame: Tumoral assessment at 4 and 8 cycles
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 17 Aug 2026.
- Results publication: PubMed 32002287Hamy AS, Derosa L, Valdelievre C, Yonekura S, Opolon P, Priour M, Guerin J, Pierga JY, Asselain B, De Croze D, Pinheiro A, Lae M, Talagrand LS, Laas E, Darrigues L, Grandal B, Marangoni E, Montaudon E, Kroemer G, Zitvogel L, Reyal F. Comedications influence immune infiltration and pathological response to neoadjuvant chemotherapy in breast cancer. Oncoimmunology. 2019 Nov 14;9(1):1677427. doi: 10.1080/2162402X.2019.1677427. eCollection 2020.
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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.
Florence LEREBOURS, MD principal investigator
Centre René Huguenin
Jean-Yves PIERGA, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemotherapy and Genomic driven chemotherapy in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 11 inclusion and 6 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Complete response rate based on the histology (time frame: Tumoral assessment at 4 and 8 cycles). 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 NCT01180335, 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 17 Aug 2026.