Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage … (NCT00295893) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
United States121 participantsStarted 2005-09-27
Plain-language summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven infiltrating ductal or lobular breast carcinoma
* Stage II or III disease
* Inflammatory breast cancer allowed
* Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status \< 2
* Male or female
* Menopausal status not specified (for female patients)
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal (except for patient's with Gilbert's disease)
* Creatinine ≤ 1.2 mg/dL
* Creatinine clearance ≥ 70 mL/min
* Ejection fraction ≥ 50% on MUGA
* No neuropathy ≥ grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception
* No prior malignant disease within the past 5 years, excluding:
* Squamous cell or basal cell skin carcinoma
* Stage I or in situ cervical carcinoma
* No noninvasive (in situ) breast carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
* At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
* No prior radiotherapy to the chest wall
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Count of Patients With Pathologic Complete Response (pCR)
Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months
2
Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.
Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.