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High-Dose chemo combo shows promise for tough breast cancers

NCT ID NCT00066443

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether giving higher doses of two chemotherapy drugs (epirubicin and docetaxel) along with a drug to boost immune recovery (pegfilgrastim) could help women with advanced or inflammatory breast cancer. 93 women took part. The goal was to see how well the treatment worked and what side effects occurred. Results were shared at a major cancer conference.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

93 people

The number who actually took part.

Started

Nov 2003

Finished

Jan 2014

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

16 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.

DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria: * T4, NX, M0 * Any T, N2-N3, M0 * Inflammatory breast cancer (redness over at least one-third of the breast), M0 * No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan * Diagnosed within the past 8 weeks * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 16 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin less than upper limit of normal (ULN) * Must meet criteria for 1 of the following: * ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN * ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * Resting LVEF normal by MUGA or echocardiogram * No congestive heart failure * No angina pectoris * No myocardial infarction within the past year * No uncontrolled hypertension * No uncontrolled arrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective non-hormonal contraception * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No symptomatic peripheral neuropathy grade 2 or greater * No active infection * No history of significant neurological or psychiatric disorders, including dementia or seizures * No peptic ulcer * No unstable diabetes mellitus * No contraindication to dexamethasone * No known sensitivity to E. coli-derived or polyethylene glycol products * Willing to undergo core biopsies once prior to registration and core biopsies at 2 other timepoints while on study * Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for breast cancer Chemotherapy * No prior chemotherapy for breast cancer Endocrine therapy * No prior hormonal therapy for breast cancer * No concurrent corticosteroids except for premedication or hypersensitivity reaction * No concurrent oral contraception Radiotherapy * No prior radiotherapy for breast cancer Surgery * No prior surgery for breast cancer other than biopsy Other * No prior systemic therapy for breast cancer * No other concurrent investigational drugs or anticancer treatment * No concurrent preventative IV antibiotics

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2, Canada

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

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