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New chemo combo shows promise for breast cancer patients

NCT ID NCT00433420

Disease control Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested different chemotherapy combinations and schedules for women with breast cancer that had spread to lymph nodes. The goal was to see if adding a drug called fluorouracil or giving chemo every 2 weeks (with a support drug to boost immune recovery) worked better than standard 3-week cycles. About 2,000 women took part, and researchers tracked how long they stayed cancer-free and any side effects.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2003

Expected to finish

Dec 2027

An estimate. End dates often move.

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 70 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: * Histologically confirmed primary breast cancer * No histology other than carcinoma * Node-positive disease * Must have at least 1 involved axillary node or internal mammary node * Previously resected disease * Has undergone radical surgery (i.e., mastectomy or conservative surgery) with axillary node dissection within the past 7 weeks * No inflammatory carcinoma * No prior or concurrent ipsilateral or contralateral invasive breast carcinoma * No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * ECOG performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * WBC ≥ 4,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No chronic liver or renal disease * No other serious medical illness requiring medication * No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin * No symptomatic peripheral neuropathy \> grade 2 * No hypersensitivity to study drugs or their components * No recent myocardial infarction, congestive heart failure, or serious arrhythmia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy * No prior cytotoxic regimens * No prior radiation therapy, except for intraoperative radiation therapy

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

More trials for these conditions

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