Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transpla… (NCT00182793) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
United States32 participantsStarted 2005-07
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. 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. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.
Who can participate
Age range
65 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 confirmed breast cancer, meeting 1 of the following stage criteria:
* Stage IIIB or IIIC disease, meeting both of the following criteria:
* Must have received prior neoadjuvant or adjuvant therapy
* Must have undergone lumpectomy or mastectomy
* Stage IV disease, meeting all of the following criteria:
* Only 1-3 organ sites with disease involvement after induction chemotherapy
* Achieved at least a partial response after induction chemotherapy
* No more than 3 lesions in the organ sites combined
* Inflammatory breast cancer allowed
* Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 65 and under
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Karnofsky 80-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT or SGPT ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.2 mg/dL
* Creatinine clearance ≥ 70 mL/min
Cardiovascular
* LVEF ≥ 55% by MUGA or echocardiogram
Pulmonary
* FEV\_1 ≥ 60% of predicted
* DLCO ≥ 60% of the lower limit of predicted value
* Oxygen saturation \> 92% on room air
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No autoimmune disorders
* No im…
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
5-Year Relapse-free Survival Rate
Timeframe: From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment
2
5-Year Overall Survival Rate
Timeframe: From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment.