S9630, Medroxyprogesterone in Treating Women With Breast Cancer
This study has been completed.
Sponsor:
Southwest Oncology Group
Collaborators:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002920
First received: November 1, 1999
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
RATIONALE: It is not yet known whether medroxyprogesterone is effective in preventing endometrial disorder in patients with breast cancer who are taking tamoxifen.
PURPOSE: Randomized phase III trial to study the effectiveness of medroxyprogesterone in preventing endometrial disorder in postmenopausal women who have ductal carcinoma in situ, lobular carcinoma in situ, Paget's disease of the nipple, stage I breast cancer, or stage II breast cancer and who are taking tamoxifen.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Endometrial Cancer |
Drug: medroxyprogesterone Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III |
Resource links provided by NLM:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Endometrial pathologic diagnosis [ Time Frame: 2 years after registration ] [ Designated as safety issue: No ]Endometrial pathologic diagnosis at 2 years after registration
Secondary Outcome Measures:
- Endometrial pathologic diagnosis [ Time Frame: 5 years after registration ] [ Designated as safety issue: No ]Endometrial pathologic diagnosis at 5 years after registration
| Enrollment: | 313 |
| Study Start Date: | March 1997 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tamoxifen alone
Tamoxifen alone x 5 years
|
Drug: tamoxifen citrate Procedure: adjuvant therapy |
|
Experimental: Tamoxifen plus MPA
Tamoxifen Plus Medroxyprogesterone Acetate (MPA) x 5 years
|
Drug: medroxyprogesterone Drug: tamoxifen citrate Procedure: adjuvant therapy |
Detailed Description:
OBJECTIVES:
- Compare endometrial pathologic diagnoses (proliferative changes, simple or cystic hyperplasia, complex adenomatous hyperplasia, hyperplasia with atypia, and carcinoma) in postmenopausal women with breast carcinoma treated with adjuvant tamoxifen who are randomly assigned to medroxyprogesterone acetate (MA) vs observation.
- Compare endometrial pathologic diagnoses (persistent endometrial hyperplasia, atypia, or carcinoma) resulting in tamoxifen discontinuation and intermittent bleeding in patients treated with these regimens.
- Characterize the incidence of spontaneous regression and progression of simple or cystic hyperplasia in these patients.
- Characterize endometrial biopsy results using different endometrial stripe width cut-off points, for cases in which the width is at least 5 mm by endovaginal ultrasound in patients receiving tamoxifen.
- Compare changes over time in endometrial oncogene expression (e.g., c-fos, c-jun, p53, IGF1) and receptor status in patients receiving tamoxifen with or without prior chemotherapy who are randomly assigned to MA vs observation.
- Describe the associations among change in gene expression, receptor status, endometrial abnormality, length of tamoxifen exposure, and prior chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to adjuvant chemotherapy (yes vs no), number of positive nodes (0-3 vs at least 4), and endovaginal sonogram endometrial stripe (less than 5 mm vs at least 5 mm). Patients are randomized to 1 of 2 arms.
All patients receive adjuvant oral tamoxifen daily for five years.
- Arm I: Patients undergo observation.
- Arm II: Patients receive oral medroxyprogesterone acetate on days 1-14. Treatment repeats every 3 months for 5 years.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
One of the following histologically proven diagnoses:
Primary invasive adenocarcinoma of the unilateral or bilateral breast
- Stage I, IIA, or IIB (T1-3, N0-1, M0)
- No recurrent invasive breast cancer
- Ductal carcinoma in situ (DCIS)
- Lobular carcinoma in situ (LCIS) with microinvasion
- Paget's disease of the nipple
- No sarcoma, lymphoma, or apocrine, adenocystic, or squamous cell cancer of the breast
Currently free of breast cancer (no evidence of disease)
- No evidence of distant disease on chest x-ray or chest CT scan and mammogram of the opposite breast within the past year
Prior definitive local treatment of primary lesion (mastectomy or breast-sparing procedure with radiotherapy) and either axillary node or sentinel node biopsy
Surgical margins clear of both infiltrating carcinoma (any type) and DCIS
No gross or microscopically positive margins except:
- Invasive cancer or DCIS at the focal margin treated with definitive radiotherapy
- Gross or LCIS at the final margin
- Biopsy requirement waived for DCIS or LCIS with minimal microinvasion
- Patients with breast-sparing procedure must have received or be planning to receive radiotherapy at start of tamoxifen treatment
- No endometrial simple or cystic hyperplasia, proliferative changes, complex (adenomatous) or atypical hyperplasia, or carcinoma
Patients must be planning one of the following:
- Starting adjuvant tamoxifen for five years OR
- Started tamoxifen within 28 days prior to study and planning to receive adjuvant tamoxifen for five years
Hormone receptor status:
- Candidate for adjuvant tamoxifen therapy
PATIENT CHARACTERISTICS:
Age:
- Adult
Sex:
- Female
Menopausal status:
Postmenopausal defined as:
- At least 1 year since last menstrual period
- At least 2 months since bilateral oophorectomy prior to breast cancer diagnosis
- 4-12 months since last menstrual period and FSH elevated to postmenopausal range
- Postmenopausal estrogen therapy and 55 years of age or older
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Fertile patients must use effective contraception during and for at least 2 months after study
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
- No concurrent nonmalignant-related illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Adjuvant chemotherapy allowed
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No prior hormonal treatment for breast cancer (except tamoxifen)
- No concurrent postmenopausal estrogen therapy
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
- No prior or concurrent hysterectomy
Other:
- No prior or current participation in an adjuvant intergroup trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002920
Show 122 Study Locations
Show 122 Study LocationsSponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Investigators
| Study Chair: | Ronald K. Potkul, MD | Loyola University |
| Study Chair: | Barbara L. Smith, MD, PhD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002920 History of Changes |
| Other Study ID Numbers: | CDR0000065314, CALGB-49901, S9630, U10CA037429, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
endometrial cancer stage I breast cancer stage II breast cancer |
ductal breast carcinoma in situ lobular breast carcinoma in situ Paget disease of the breast |
Additional relevant MeSH terms:
|
Breast Neoplasms Endometrial Neoplasms Adenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Medroxyprogesterone |
Medroxyprogesterone Acetate Tamoxifen Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 23, 2013