Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer (NCT00003042) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
United States41 participantsStarted 1997-05-30
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.
Who can participate
Age range
18 Years – 60 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 stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin
* Diagnosis within the past 6 months
PATIENT CHARACTERISTICS:
Age:
* 60 and under
Performance status:
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGOT or SGPT no greater than 1.5 times the upper limit of normal
Renal:
* Creatinine less than 1.2 mg/dL
* Creatinine clearance at least 80 mL/min
* No history of hemorrhagic cystitis
Cardiovascular:
* Left ventricular fraction at least 55% on MUGA scan
* No previous valvular heart disease or arrhythmia
Pulmonary:
* FEV\_1 at least 60% predicted
* Room air pO\_2 greater than 85 mmHg
* Room air pCO\_2 no greater than 43 mmHg
* DLCO at least 60% of the lower limit of predicted value
Other:
* No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer
* No organic CNS dysfunction
* Not pregnant
* No known and potentially disabling psychosocial history
* Not positive for hepatitis B or HIV
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Stratum 1:
* No more than one cycle of chemotherapy
* Stratum 2:
* No greater than 225 mg/m\^2 doxorubicin…
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
Three-year Relapse-free Survival
Timeframe: From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.
2
Five-year Overall Survival
Timeframe: From date of mastectomy until date of death, 5 years post mastectomy.