Breast CancerPhase 3NCT00003972
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer
A Phase 3 study testing filgrastim, sargramostim and busulfan in people with Breast Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, sargramostim and busulfan
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Mar 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven stage II breast cancer with 1 of the following: Estrogen receptor negative with at least 4 positive nodes OR Estrogen receptor positive with at least 6 positive nodes OR Histologically proven stage IIIA breast cancer Must have already received 4-7 courses of conventional chemotherapy with a doxorubicin based regimen (which may include paclitaxel or docetaxel) No greater than 60 days since induction chemotherapy Prior definitive surgical treatment of primary lesion (modified radical mastectomy or breast conserving procedure plus axillary node dissection) Margins free of tumor Hormone receptor status: Estrogen and progesterone receptor status known
PATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% if any of the following: Symptoms of congestive heart failure Abnormal cardiac exam Prior doxorubicin dose greater than 400 mg/m2 Pulmonary: No significant pulmonary disease (DLCO less than 60% predicted) Other: Not pregnant Negative pregnancy test HIV negative No significant active infection No other severe disease that would severely limit life expectancy No other malignancy within past 5 years unless: Chance of survival for greater than 5 years is 90% AND Treated with surgery only (no chemotherapy or radiotherapy)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior chemotherapy regimen (no greater than 7 prior courses) Endocrine therapy: No concurrent tamoxifen Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent experimental agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase III Study of High-Dose Chemotherapy Using Busulfan, Melphalan and Thiotepa Versus Cyclophosphamide,Thiotepa, Carboplatin Followed by Autologous Stem Cell Transplantation in Patients With High-Risk Primary Stage II or III (Non-Inflammatory) Breast Cancer
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. It is not yet known which regimen of combination chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES: I. Compare early mortality, survival, and disease free survival in patients with node positive stage II or IIIA breast cancer treated with busulfan, melphalan, and thiotepa versus cyclophosphamide, thiotepa, and carboplatin followed by autologous peripheral blood stem cell transplantation. II. Compare the toxicity of these 2 regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to stage of disease (stage II vs stage IIIA), lymph node status (at least 10 positive nodes vs less than 10 positive nodes), and hormone receptor status (estrogen receptor positive or progesterone receptor positive vs estrogen receptor negative or progesterone receptor negative). All patients initially receive mobilization chemotherapy with cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Beginning on day 4, patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously each day until the final day of leukapheresis. When blood counts recover, peripheral blood stem cells (PBSC) are harvested. Patients are randomized to 1 of 2 high dose chemotherapy regimens 28-45 days after the last dose of mobilization chemotherapy. Arm I: Patients receive oral busulfan every 6 hours on days -8 to -6, melphalan IV over 30-60 minutes on days -5 and -4, and thiotepa IV over 2 hours on days -3 and -2. PBSC are reinfused on day 0. Arm II: Patients receive cyclophosphamide, thiotepa, and carboplatin by continuous IV infusion over 24 hours on days -7, to -4. PBSC are reinfused on day 0. Beginning 4-6 weeks after the last dose of chemotherapy, patients in both arms receive local radiotherapy 5 days each week for 5 weeks. Patients also receive oral tamoxifen (or equivalent antiestrogen therapy) daily for 5 years if they are estrogen or progesterone receptor positive, postmenopausal, or age 50 and over and perimenopausal. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study over 3 years.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, sargramostim, busulfan, carboplatin, cyclophosphamide
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
sargramostimBiological
busulfanDrug
carboplatinDrug
cyclophosphamideDrug
melphalanDrug
paclitaxelDrug
tamoxifen citrateDrug
thiotepaDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startJul 1998
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William I. Bensinger, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003972
- Sponsor's protocol ID
- 1316.00
- Other IDs
- FHCRC-1316.00, PSOC-1604, NCI-G99-1552, CDR0000067175
- Status last verified
- Mar 2010
- First submitted
- 1 Nov 1999
- Last updated
- 2 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of High-Dose Chemotherapy Using Busulfan, Melphalan and Thiotepa Versus Cyclophosphamide,Thiotepa, Carboplatin Followed by Autologous Stem Cell Transplantation in Patients With High-Risk Primary Stage II or III (Non-Inflammatory) Breast Cancer
- ClinicalTrials.gov ID
- NCT00003972
- Acronym / sponsor ID
- 1316.00
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1998
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 3 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It is not yet known which regimen of combination chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer.
Detailed description
OBJECTIVES: I. Compare early mortality, survival, and disease free survival in patients with node positive stage II or IIIA breast cancer treated with busulfan, melphalan, and thiotepa versus cyclophosphamide, thiotepa, and carboplatin followed by autologous peripheral blood stem cell transplantation. II. Compare the toxicity of these 2 regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to stage of disease (stage II vs stage IIIA), lymph node status (at least 10 positive nodes vs less than 10 positive nodes), and hormone receptor status (estrogen receptor positive or progesterone receptor positive vs estrogen receptor negative or progesterone receptor negative). All patients initially receive mobilization chemotherapy with cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Beginning on day 4, patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously each day until the final day of leukapheresis. When blood counts recover, peripheral blood stem cells (PBSC) are harvested. Patients are randomized to 1 of 2 high dose chemotherapy regimens 28-45 days after the last dose of mobilization chemotherapy. Arm I: Patients receive oral busulfan every 6 hours on days -8 to -6, melphalan IV over 30-60 minutes on days -5 and -4, and thiotepa IV over 2 hours on days -3 and -2. PBSC are reinfused on day 0. Arm II: Patients receive cyclophosphamide, thiotepa, and carboplatin by continuous IV infusion over 24 hours on days -7, to -4. PBSC are reinfused on day 0. Beginning 4-6 weeks after the last dose of chemotherapy, patients in both arms receive local radiotherapy 5 days each week for 5 weeks. Patients also receive oral tamoxifen (or equivalent antiestrogen therapy) daily for 5 years if they are estrogen or progesterone receptor positive, postmenopausal, or age 50 and over and perimenopausal. Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| sargramostim | Biological | – |
| busulfan | Drug | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| melphalan | Drug | – |
| paclitaxel | Drug | – |
| tamoxifen citrate | Drug | – |
| thiotepa | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William I. Bensinger, MD study chair
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim, sargramostim and busulfan in people with Breast Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.