High-Dose chemo combo shows promise for tough breast cancers
NCT ID NCT00066443
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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93 people
The number who actually took part.
- Started
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Nov 2003
- Finished
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Jan 2014
- Lead sponsor
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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
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16 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2L 4L2, Canada
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CHA-Hopital Du St-Sacrement
Québec, Quebec, G1S 4L8, Canada
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CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
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Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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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.
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