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Exemestane or Anastrozole in Treating Postmenopausal Women With Hormone Receptor-Positive Primary Breast Cancer

2014-08-27 03:39:59 | BioPortfolio

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane or anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane or anastrozole after surgery may keep breast cancer from growing or coming back. It is not yet known whether exemestane is more effective than anastrozole in treating breast cancer.

PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared with anastrozole in treating postmenopausal women with hormone receptor-positive primary breast cancer.

Description

OBJECTIVES:

Primary

- Compare the event-free survival of postmenopausal women with hormone receptor-positive breast cancer treated with adjuvant exemestane vs anastrozole.

Secondary

- Compare the overall survival of patients treated with these regimens.

- Compare the time to distant recurrence in patients treated with these regimens.

- Compare the incidence of new contralateral primary breast cancer in patients treated with these regimens.

- Compare the incidence of all clinical fractures, specifically hip and vertebral fractures, in patients treated with these regimens.

- Compare cardiovascular morbidity and mortality in patients treated with these regimens.

- Compare the toxicities of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to lymph node status (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and trastuzumab (Herceptin^®) use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral exemestane once daily.

- Arm II: Patients receive oral anastrozole once daily. In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed annually.

PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.

Study Design

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

Conditions

Breast Cancer

Intervention

anastrozole, exemestane, adjuvant therapy

Status

Active, not recruiting

Source

NCIC Clinical Trials Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:59-0400

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Medical and Biotech [MESH] Definitions

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Combined chemotherapy and radiotherapy given to augment some other form of treatment such as surgery. It is commonly used in the therapy of cancer.

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