Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer (NCT00006110) | Clinical Trial Compass
CompletedPhase 2
Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer
United States82 participantsStarted 1998-12
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.
Who can participate
Age range
1 Year – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast
* Fine needle aspiration, core needle biopsy, or incisional biopsy allowed
* No excisional biopsy
* Any of the following:
* Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)
* Any T with N2 (including axillary lymph nodes matted to one another) or N3
* Any T4, including inflammatory breast cancer
* Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor
* Supraclavicular or infraclavicular positive lymph nodes without distant metastases
* Distant metastases with measurable disease in breast or lymph nodes
* Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age: Not specified
Sex: Female
Menopausal status: Not specified
Performance status: Not specified
Life expectancy: Not specified
Hematopoietic:
White cell count \> 3000 / mm3 Platelet count \> 100,000 / mm3
Hemoglobin \> 9 mg / dl Bilirubin \< 1.5 x normal Creatinine \< 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Exclusions
Prior malignancies except:
Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has…
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
Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.