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Gene test may predict chemo side effects in breast cancer patients

NCT ID NCT00953537

Knowledge-focused Sponsor: Centre Antoine Lacassagne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at whether a deficiency in the DPD enzyme can predict severe side effects from the chemotherapy drug capecitabine in women with metastatic breast cancer. Researchers analyzed blood samples from 303 participants to see if genetic differences could help doctors plan safer treatment. The goal was to reduce risks like diarrhea and hand-foot syndrome by identifying vulnerable patients beforehand.

What this could mean

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

Active substance
capecitabine
What this could lead to
If successful, this could help doctors identify patients at risk for severe side effects from capecitabine, allowing safer, more personalized treatment plans.
What could go wrong
This is a small, completed pilot study, so results may not apply broadly. The focus is on predicting toxicity, not improving outcomes, and the approach may not be ready for routine use.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

303 people

The number who actually took part.

Start date

Jan 2009

Finished

Feb 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 to 120 years

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.

DISEASE CHARACTERISTICS: * Radiologically (by scintography) or histologically confirmed metastatic breast cancer * At least 1 measurable or evaluable target lesion * Receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab) * No uncontrolled brain metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 3 months * Fertile patients must use effective contraception * No chronic uncontrolled illness * No congestive heart failure * No peripheral venous disease * No severe uncontrolled infection * No hypoxemic respiratory failure * No prior primary cancer except for basal cell carcinoma of the skin * No psychologic disorder PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No capecitabine co-administered with chemotherapy

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

More trials for these conditions

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