Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Breast Neoplasms

Osteoporosis

Hot Flashes

Breast Diseases

Skin Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Menopause

All Drugs and Chemicals

Estrogens, Conjugated (USP)

Hormones

Estrogens

Progesterone

Progestins

Hormone Antagonists

therapeutic progesterone

conjugated estrogens

Jenni Parmar, RN

RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer.

PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage I or stage II breast cancer.

OBJECTIVES:

* Compare disease-free survival and overall survival of postmenopausal women with prior stage I or II breast cancer treated with hormone replacement therapy (HRT) vs nonhormonal alternatives to HRT.
* Compare relief of menopausal symptoms and quality of life of patients treated with these regimens.
* Compare cardiovascular and osteoporotic events in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (\< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs \> 2 to \< 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without progesterone for at least 2 years.
* Arm II: Patients are offered advice on nonhormonal HRT alternatives. Menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter.

Patients are followed every 6 months for 3 years and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study.

Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer

UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer

Institute of Cancer Research, United Kingdom

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Adenocarcinoma

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Richard R. Barakat, MD

Scott Wadler, MD

David S. Alberts, MD

RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.

OBJECTIVES:

* Determine the effect of estrogen replacement therapy on recurrence free and overall survival in women with a history of stage I or II endometrial adenocarcinoma.

OUTLINE: This is a randomized, double blind study. Patients are stratified according to stage of endometrial cancer (IA vs IB/IC vs II). Patients are randomized to one of two treatment arms:

* Arm I: Patients receive oral conjugated estrogens (Premarin) daily for 3 years.
* Arm II: Patients receive oral placebo daily for 3 years. Patients are followed every 6 months for 3 years and then annually for 2 years.

PROJECTED ACCRUAL: Approximately 2,108 patients will be accrued for this study.

Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer

A Randomized Double-Blinded Trial of Estrogen Replacement Therapy Versus Placebo in Women With Stage I or II Endometrial Adenocarcinoma

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

SWOG Cancer Research Network

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer	NCT00079248	Breast Cancer Hot Flashes Menopausal Symp... Osteoporosis	therapeutic pro... conjugated estr...	-	National Cancer Institute (NCI)
Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer	NCT00002976	Endometrial Can...	conjugated estr...	-	GOG Foundation

Spots Global Cancer Trial Database for conjugated estrogens