SWOG clinical trial number
S9630

A Randomized Comparison of Medroxyprogesterone Acetate (MPA) and Observation For Prevention of Endometrial Pathology in Postmenopausal Breast Cancer Patients Treated with Tamoxifen

Closed
Phase
Accrual
95%
Published
Abbreviated Title
ADJUVANT: MPA vs. Observation in Tamoxifen-Treated Patients
Activated
03/15/1997
Closed
12/15/2004
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB

Research committees

Breast Cancer

Treatment

Medroxyprogesterone acetate Tamoxifen Surgery

Eligibility Criteria Expand/Collapse

Primary unilateral or bilateral invasive adenoca of the breast, DCIS or LCIS WITH microinvasion; no "pure" LCIS, sarcoma, lymphoma, apocrine, adenocystic or squamous cell ca of the breast; no recurrent invasive breast ca; prior, ongoing or planned adjuvant chemotherapy OK; no prior hormonal treatment (other than tamoxifen) for breast ca; cannot be currently eligible or previously treated on any adjuvant intergroup study; no concurrent chemotherapy; must have had definitive local treatment of primary lesion and axillary node sampling or sentinal node biopsy required unless DCIS or LCIS as specified in protocol; patient must be candidate for tamoxifen, or ER and PgR unknown; tumor staged as T1-3, N0-1 and M0; currently free of disease, female, postmenopausal, no prior hysterectomy.

CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 0.8 (INCREASED FROM 0.5 TO 0.8 AS OF 6/1/99)

Publication Information Expand/Collapse

2017

How do we increase uptake of tamoxifen and other anti-estrogens for breast cancer prevention?

KD Crew;DL Hershman;JM Unger;S Lo NPJ Breast Cancer May 19;3:20

PMid: PMID28649660 | PMC number: PMC5460136

2016

A phase III randomized comparison of medroxyprogesterone acetate versus observation for the prevention of endometrial pathology in postmenopausal patients with breast cancer treated with adjuvant tamoxifen: SWOG S9630

R Potkul;J Unger;R Livingston;S Wilczynski;C Salomon;B Smith;L Wong;DL Campbell;D Einspahr;G Anderson;G Goodman;P Brown;F Meyskens;K Albain NPJ Breast Cancer Aug 10;2:16024

PMid: PMID28721383 | PMC number: PMC5515330

Randomized trial of medroxyprogesterone acetate for prevention of endometrial pathology from adjuvant tamoxifen for breast cancer: SWOG S9630 (ClinicalTrials.gov NCT00002920)

K Albain;J Unger;R Livingston;K Crew;S Wilczynski;C Salomon;BL Smith;L Wong;DL Campbell;D Einspahr;G Anderson;D Hershman;G Goodman;PH Brown;F Meyskens;R Potkul Journal of Clinical Oncology 34, 2016 (suppl; abstr 547); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), poster session