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Personalized chemo: could tumor DNA hold the key to better breast cancer treatment?

NCT ID NCT01180335

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial is testing whether choosing chemotherapy based on the genetic profile of a patient's breast tumor can improve treatment response compared to standard chemotherapy. Women with HER2-negative breast cancer that is not eligible for conservative surgery will be randomly assigned to receive either standard chemo or a regimen selected based on specific gene activity in their tumor. The goal is to see if the genomic-driven approach leads to a higher rate of complete response before surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genomic-driven chemotherapy (paclitaxel, FEC, docetaxel, capecitabine) chosen based on tumor gene activity
What this could lead to
If successful, this could show that tailoring chemotherapy to a patient's tumor genetics improves treatment response and outcomes for breast cancer.
What could go wrong
The trial is still in progress, and results are not yet known. The genetic approach may not prove better than standard chemo, and side effects from the drugs remain a risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

303 people

The number who actually took part.

Start date

Jan 2009

Finished

Dec 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Signed written informed consent * PS 0-1 * No previous treatment for breast cancer * Adequate organ function * FEVG \>50% Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Institut Gustave Roussy

    Villejuif, 94800, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.