Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032136
• Other study ID #: CRC-TU-TEAM
• Secondary ID: CDR0000069260EU-
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2002
• Last updated: August 1, 2013
• Start date: December 2001
• Est. completion date: April 2009

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer.

Description:

OBJECTIVES:

• Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer.

• Compare the relapse-free survival and overall survival of patients treated with these drugs.

• Compare the incidence of contralateral breast cancer in patients treated with these drugs.

• Compare the safety and long-term tolerability of these drugs in these patients.

• Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or more nodes positive). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral tamoxifen once daily

• Arm II: Patients receive oral exemestane once daily. Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at months 3 and 12 during study.

Patients are followed at least annually.

PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4400
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed early adenocarcinoma of the breast

• Completely excised by surgery with curative intent (R0)

• Any N OR

• Any primary tumor greater than 3 cm OR

• Any primary tumor grade III and greater than 1 cm

• M0

• No positive supraclavicular nodes

• Hormone receptor status:

• Estrogen and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age:

• Any age

• See Menopausal status

Sex:

• Female

Menopausal status:

• Postmenopausal

• Any age with bilateral oophorectomy or amenorrhea for at least 5 years OR

• Age 50 or over:

• Natural amenorrhea for at least 1 year OR

• Chemotherapy-induced amenorrhea for at least 2 years OR

• Radiation-induced amenorrhea (at least 3 months since prior radiotherapy) OR

• Under age 50:

• If amenorrheic for less than 5 years (any cause) or prior hysterectomy without bilateral surgical oophorectomy, follicle-stimulating hormone must be assayed to confirm postmenopausal status

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 100,000/mm3

• WBC greater than 3,000/mm3

Hepatic:

• SGOT or SGPT less than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine less than 1.5 times ULN

Cardiovascular:

• No uncontrolled cardiac disease

• No unstable angina

• No congestive heart failure or arrhythmia requiring medical therapy

• No myocardial infarction within the past 3 months

Other:

• No severe osteoporosis

• No other malignancies within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer

• No other serious concurrent disease that would preclude study

• No psychiatric disorders that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior neoadjuvant chemotherapy

• No more than 10 weeks since completion of prior adjuvant chemotherapy

Endocrine therapy:

• No prior adjuvant hormonal therapy for breast cancer

• No prior neoadjuvant hormonal therapy (prior to surgery) for duration of more than 4 weeks

• At least 4 weeks since prior hormone replacement therapy

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

• No more than 10 weeks since completion of curative surgery

Other:

• No other concurrent investigational agents or participation in another clinical study (except adjuvant cytotoxic chemotherapy studies)

• Concurrent bisphosphonates allowed

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• exemestane

• tamoxifen citrate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United Kingdom	City Hospital - Birmingham	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Campaign Clinical Trials Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Hadji P, Asmar L, van Nes JG, Menschik T, Hasenburg A, Kuck J, Nortier JW, van de Velde CJ, Jones SE, Ziller M. The effect of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis of the US, German, Netherlands, and Belgium sub-studies. J Cancer Res Clin Oncol. 2011 Jun;137(6):1015-25. doi: 10.1007/s00432-010-0964-y. Epub 2010 Dec 18. — View Citation

Hadji P, Ziller M, Kieback DG, Dornoff W, Tessen HW, Menschik T, Kuck J, Melchert F, Hasenburg A. Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospect — View Citation

Hadji P, Ziller M, Kieback DG, Menschik T, Kalder M, Kuck J, Hasenburg A. The effect of exemestane or tamoxifen on markers of bone turnover: results of a German sub-study of the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial. Breast. 2009 Jun;18(3 — View Citation

Kieback DG, Harbeck N, Bauer W, Hadji P, Weyer G, Menschik T, Hasenburg A. Endometrial effects of exemestane compared to tamoxifen within the Tamoxifen Exemestane Adjuvant Multicenter (TEAM) trial: results of a prospective gynecological ultrasound substud — View Citation

van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival			No
Secondary	Overall survival			No
Secondary	Incidence of second breast cancer in contralateral breast			No
Secondary	Safety and long term tolerability			Yes
Secondary	Quality of life			No