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Math models may tame chemo side effects in breast cancer

NCT ID NCT02392845

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested whether using mathematical models to schedule chemotherapy drugs docetaxel and epirubicin could reduce severe side effects in 17 patients with metastatic breast cancer. The goal was to find the safest dose and schedule while still giving six cycles of treatment. Researchers focused on managing toxicities like vomiting and mouth sores, not on curing the cancer.

What this could mean

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

Active substance
docetaxel and epirubicin (chemotherapy drugs)
What this could lead to
If successful, this approach could help doctors give stronger chemotherapy doses more safely by using math models to reduce severe side effects.
What could go wrong
This is a very early, small phase 1 trial with only 17 participants, so results may not apply broadly. The main goal was safety, not effectiveness against cancer.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Start date

Jun 2005

Finished

Mar 2009

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: * Age ≥ 18 years, * ECOG performance status ≤ 2 * Diagnosed with metastatic HER2-negative hormone-resistant chemotherapy-naive breast cancers, previous adjuvant chemotherapy treatment are allowed. * Histologically or cytologically proven breast cancer metastases or associated with CA 15-3 levels 50% above the normal value * Hormone resistance defined by the presence of negative hormone receptors or disease progression within 6 months of the initiation of hormone therapy. * Adequate renal and liver function (ASAT and ALAT \< twice the upper limit normal value (ULN) if no liver metastases, or \< 4×ULN if liver metastases; total bilirubin \< 2×ULN), * Adequate cardiac function (left ventricular ejection fraction (LVEF) \> 50%), * Neutrophils ≥ 1200/mm3 * Platelets ≥ 105/mm3 Exclusion Criteria: * Cerebral metastases and meningeal involvement, * Other malignant diseases, * Significant comorbidities, * Previous chemotherapy for metastatic disease, or previous chemotherapy with a total cumulative dose greater than 600 mg/m² for EPI or greater than 450 mg/m² for DTX

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone-resistant breast carcinoma

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • Gilles FREYER , Professor 04 78 86 43 18 Ext. +33 [email protected]

    Lyon, 69002, France

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