Breast CancerPhase 3NCT00002696
Combination Chemotherapy in Treating Women With Stage III Breast Cancer
A Phase 3 study testing CAF regimen, CMF regimen and cyclophosphamide in people with Breast Cancer, run by Grupo Oncologico Cooperativo del Sur at 7 sites in Argentina.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and… Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CAF regimen, CMF regimen and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 7 sitesArgentina
- Study dates
- Oct 1995to not given
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III breast cancer
- Measurable disease
- No inflammatory breast cancer
- No synchronous bilateral breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 21 to 75
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1 OR
- Zubrod 0-1
Life expectancy:
- More than 12 weeks
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.25 times upper limit of normal (ULN)
- AST less than 1.25 times ULN
Renal:
- Creatinine clearance greater than 70 mL/min
Cardiovascular:
- No angina pectoris
- No significant arrhythmia requiring therapy
- No bilateral bundle branch block
- No congestive heart failure
- No myocardial infarction
Other:
- No medical or psychiatric disease that would preclude study therapy
- No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- No prior surgery except incisional biopsy or fine-needle aspiration
Other:
- No prior systemic therapy
- No concurrent caffeine or alcohol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Argentina7 sites
Policlinica Privada Instituto De Medicina Nuclear
Bahía Blanca, Buenos Aires, 8000
Consultorio Oncologico Privado
Mar del Plata, Buenos Aires, 7600
Unidad Oncologica Del Comahue
Neuquén, Neuquén Province
Consultorio Oncologico Privado
Río Gallegos, 9400
Centro Oncologico Del Litoral
Santa Fe, 3000
Centro De Oncologia y Terapia Radiante
Santa Rosa, La Pampa Province, 6300
Centro Oncologico Tres Arroyos
Tres Arroyos, 7500
About this study
Official title: MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
- Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the compliance of patients treated with these regimens.
- Assess the cosmetic results in patients treated with conservative surgery.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center.
- Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3 courses in the absence of disease progression.
- Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF). Treatment continues every 4 weeks for 3 courses in the absence of disease progression.
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).
Quality of life is assessed at baseline and then monthly thereafter.
Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
- Conditions
- Breast Cancer
- Being tested
- CAF regimen, CMF regimen, cyclophosphamide, doxorubicin hydrochloride, fluorouracil
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
CAF regimenDrug
CMF regimenDrug
cyclophosphamideDrug
fluorouracilDrug
methotrexateDrug
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure 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 posted27 Jan 2003 (estimated)
- Study startOct 1995
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.
- 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
Sponsor and investigators
- Lead sponsor
- Grupo Oncologico Cooperativo del Sur
- Sponsor type
- University, hospital or other
- Investigators
- Bernardo A. Leone, MD, Study chair, Unidad Oncologica Del Neuquen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002696
- Sponsor's protocol ID
- GOCS-08-BR-95-III
- Other IDs
- CDR0000064471, NCI-F95-0036
- Status last verified
- Apr 2008
- First submitted
- 1 Nov 1999
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
- ClinicalTrials.gov ID
- NCT00002696
- Acronym / sponsor ID
- GOCS-08-BR-95-III
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Lead sponsor
- Grupo Oncologico Cooperativo del SurUniversity, hospital or other
- Study start
- Oct 1995
- First posted
- 27 Jan 2003 (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 more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.
Detailed description
OBJECTIVES:
- Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
- Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the compliance of patients treated with these regimens.
- Assess the cosmetic results in patients treated with conservative surgery.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center.
- Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3 courses in the absence of disease progression.
- Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF). Treatment continues every 4 weeks for 3 courses in the absence of disease progression.
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).
Quality of life is assessed at baseline and then monthly thereafter.
Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 to 75 years
- 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 |
|---|---|---|
| CAF regimen | Drug | – |
| CMF regimen | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| fluorouracil | Drug | – |
| methotrexate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Bernardo A. Leone, MD study chair
Unidad Oncologica Del Neuquen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAF regimen, CMF regimen and cyclophosphamide in people with Breast Cancer, run by Grupo Oncologico Cooperativo del Sur at 7 sites in Argentina.
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: paused, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Argentina. 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?
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?
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 Aug 2013.