Breast CancerPhase 3NCT00002772
S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
A Phase 3 study testing filgrastim, carboplatin and carmustine in people with Breast Cancer, run by SWOG Cancer Research Network 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. 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 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, carboplatin and carmustine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to Feb 2004
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least 4 involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal lymphatic involvement without clinical inflammatory changes (edema, peau d'orange, erythema) allowed Must have undergone breast conserving surgery or modified radical mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4 weeks of initial histologic diagnosis One breast meets the eligibility criteria Other breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by modified radical mastectomy or breast conserving surgery with axillary node dissection Concurrent registration on S9719 Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No second or third degree heart block or other serious cardiac conduction abnormality No atrial or ventricular arrhythmia No requirement for medication known to affect cardiac conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted Other: HIV negative Hepatitis B surface antigen status required No serious medical or psychiatric illness that would preclude informed consent or study participation No second malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy: No prior radiotherapy to the breast Surgery: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.
Read the detailed description
OBJECTIVES: I. Compare disease free survival and overall survival in women with operable breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide versus standard dose doxorubicin and cyclophosphamide followed by high dose STAMP I (cyclophosphamide, cisplatin, and carmustine) or STAMP V (cyclophosphamide, carboplatin, and thiotepa) and autologous stem cell rescue. II. Compare the toxic effects of these regimens in this patient population. III. Measure the breast cancer cell content of the peripheral blood progenitor cell (PBPC) fractions from patients randomized to the PBPC supported arm and correlate the results with the disease free survival, survival, and pattern of relapse in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, primary treatment (mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy), menopausal status (premenopausal vs postmenopausal), estrogen and/or progesterone receptor status (positive vs negative vs unknown), N2 disease (yes vs no), T3 disease (yes vs no), myeloablative chemotherapy regimen (STAMP I vs STAMP V), and source of progenitor cells (marrow vs peripheral blood vs both). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive doxorubicin IV over 1 hour on days 1, 15, and 29, paclitaxel IV over 24 hours on days 43, 57, and 71, and cyclophosphamide IV over 1 hour on days 85, 99, and 113. Patients receive filgrastim (G-CSF) subcutaneously on days 3-10, 17-24, 31-38, 45-52, 59-66, 73-80, 87-94, 101-108, and 115-122. Arm II: Mobilization chemotherapy: Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1, 22, 43, and 64. Harvest: Patients undergo harvest of autologous bone marrow and/or peripheral blood stem cells (PBSC). Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest. High dose myeloablative chemotherapy: Patients receive STAMP I OR STAMP V: STAMP I: Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3. STAMP V: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Transplantation: Autologous bone marrow and/or PBSC are reinfused on day 0. Both arms: Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years. Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 4.5-5.5 weeks beginning 4-6 weeks after the completion of chemotherapy. Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician. Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study within 5 years.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, carboplatin, carmustine, cisplatin, 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
carboplatinDrug
carmustineDrug
cisplatinDrug
cyclophosphamideDrug
paclitaxelDrug
tamoxifen citrateDrug
thiotepaDrug
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| High dose chemo | Experimental | sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Drug: tamoxifen citrate; Radiation: radiation therapy |
| chemo with autologous stem cell support | Experimental | conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support Receives: Drug: carboplatin; Drug: carmustine; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Drug: tamoxifen citrate; Drug: thiotepa; Procedure: autologous bone marrow transplantation; Procedure: peripheral blood stem cell transplantation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2004 (estimated)
- Study startJul 1996
- Primary completionFeb 2004
- Study completionFeb 2004
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
- Responsible party
- Sponsor
- Investigators
- Scott I. Bearman, MD, Study chair, University of Colorado, DenverAntonio C. Wolff, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsClifford A. Hudis, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002772
- Sponsor's protocol ID
- CDR0000064747
- Other IDs
- S9623, U10CA032102
- Status last verified
- Jan 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moore HC, Green SJ, Gralow JR, Bearman SI, Lew D, Barlow WE, Hudis C, Wolff AC, Ingle JN, Chew HK, Elias AD, Livingston RB, Martino S; Southwest Oncology Group/Intergroup Study 9623. Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623. J Clin Oncol. 2007 May 1;25(13):1677-82. doi: 10.1200/JCO.2006.08.9383. Epub 2007 Apr 2.
PubMed 17404368Bearman SI, Green S, Gralow J, et al.: SWOG/Intergroup 9623: a phase III comparison of intensive sequential chemotherapy to high dose chemotherapy and autologous hematopoietic progenitor cell support (AHPCS) for primary breast cancer in women with =4 involved axillary lymph nodes. [Abstract] J Clin Oncol 23 (Suppl 16): A-572, 21s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes
- ClinicalTrials.gov ID
- NCT00002772
- Acronym / sponsor ID
- CDR0000064747
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 602 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B
- Study start
- Jul 1996
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 22 Apr 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. 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 chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.
Detailed description
OBJECTIVES: I. Compare disease free survival and overall survival in women with operable breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide versus standard dose doxorubicin and cyclophosphamide followed by high dose STAMP I (cyclophosphamide, cisplatin, and carmustine) or STAMP V (cyclophosphamide, carboplatin, and thiotepa) and autologous stem cell rescue. II. Compare the toxic effects of these regimens in this patient population. III. Measure the breast cancer cell content of the peripheral blood progenitor cell (PBPC) fractions from patients randomized to the PBPC supported arm and correlate the results with the disease free survival, survival, and pattern of relapse in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, primary treatment (mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy), menopausal status (premenopausal vs postmenopausal), estrogen and/or progesterone receptor status (positive vs negative vs unknown), N2 disease (yes vs no), T3 disease (yes vs no), myeloablative chemotherapy regimen (STAMP I vs STAMP V), and source of progenitor cells (marrow vs peripheral blood vs both). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive doxorubicin IV over 1 hour on days 1, 15, and 29, paclitaxel IV over 24 hours on days 43, 57, and 71, and cyclophosphamide IV over 1 hour on days 85, 99, and 113. Patients receive filgrastim (G-CSF) subcutaneously on days 3-10, 17-24, 31-38, 45-52, 59-66, 73-80, 87-94, 101-108, and 115-122. Arm II: Mobilization chemotherapy: Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1, 22, 43, and 64. Harvest: Patients undergo harvest of autologous bone marrow and/or peripheral blood stem cells (PBSC). Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest. High dose myeloablative chemotherapy: Patients receive STAMP I OR STAMP V: STAMP I: Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3. STAMP V: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. Transplantation: Autologous bone marrow and/or PBSC are reinfused on day 0. Both arms: Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years. Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 4.5-5.5 weeks beginning 4-6 weeks after the completion of chemotherapy. Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician. Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose chemo | Experimental | Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: paclitaxel, Drug: tamoxifen citrate, Radiation: radiation therapysequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support |
| chemo with autologous stem cell support | Experimental | Drug: carboplatin, Drug: carmustine, Drug: cisplatin, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: paclitaxel, Drug: tamoxifen citrate, Drug: thiotepa, Procedure: autologous bone marrow transplantation, Procedure: peripheral blood stem cell transplantationconventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 | High dose chemo |
| carboplatin | Drug | chemo with autologous stem cell support |
| carmustine | Drug | chemo with autologous stem cell support |
| cisplatin | Drug | chemo with autologous stem cell support |
| cyclophosphamide | Drug | High dose chemo, chemo with autologous stem cell support |
| doxorubicin hydrochloride | Drug | High dose chemo, chemo with autologous stem cell support |
| paclitaxel | Drug | High dose chemo, chemo with autologous stem cell support |
| tamoxifen citrate | Drug | High dose chemo, chemo with autologous stem cell support |
| thiotepa | Drug | chemo with autologous stem cell support |
| autologous bone marrow transplantation | Procedure or surgery | chemo with autologous stem cell support |
| peripheral blood stem cell transplantation | Procedure or surgery | chemo with autologous stem cell support |
| radiation therapy | Radiation | High dose chemo |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Results publication: PubMed 17404368Moore HC, Green SJ, Gralow JR, Bearman SI, Lew D, Barlow WE, Hudis C, Wolff AC, Ingle JN, Chew HK, Elias AD, Livingston RB, Martino S; Southwest Oncology Group/Intergroup Study 9623. Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623. J Clin Oncol. 2007 May 1;25(13):1677-82. doi: 10.1200/JCO.2006.08.9383. Epub 2007 Apr 2.
- Results publicationBearman SI, Green S, Gralow J, et al.: SWOG/Intergroup 9623: a phase III comparison of intensive sequential chemotherapy to high dose chemotherapy and autologous hematopoietic progenitor cell support (AHPCS) for primary breast cancer in women with =4 involved axillary lymph nodes. [Abstract] J Clin Oncol 23 (Suppl 16): A-572, 21s, 2005.
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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.
Scott I. Bearman, MD study chair
University of Colorado, Denver
Antonio C. Wolff, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Clifford A. Hudis, MD study chair
Memorial Sloan Kettering 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, carboplatin and carmustine in people with Breast Cancer, run by SWOG Cancer Research Network 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: stopped early, as of the sponsor's last update on 24 Jan 2013. 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 was stopped early (reason given: poor accrual). Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT00002772, which also lists 2 linked publications.
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 24 Jan 2013.