Advertisement

Topics

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

Clinical Trials [5684 Associated Clinical Trials listed on BioPortfolio]

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defin...

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the...

Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients

This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundr...

Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer

The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sen...

Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by th...

PubMed Articles [21737 Associated PubMed Articles listed on BioPortfolio]

Risk of cardiac disease after adjuvant radiation therapy among breast cancer survivors.

Adjuvant radiation therapy (RT) for breast cancer is associated with heart disease, although the impact of patient-specific factors on the interaction between cardiac risk and RT is not well-studied i...

Everolimus-based combination therapies for HR+, HER2- metastatic breast cancer.

Metastatic breast cancer (MBC) is the leading cause of cancer-related morbidity and mortality among women worldwide. Endocrine therapy is the standard of care for the most common subtype of MBC, hormo...

Evolution in sites of recurrence over time in breast cancer patients treated with adjuvant endocrine therapy.

Hormone receptor positive breast cancer is characterized by a prolonged risk of recurrence. Extended adjuvant endocrine therapy improves disease-free survival (DFS), but no effect on overall survival ...

Current Status of Extended Adjuvant Endocrine Therapy in Early Stage Breast Cancer.

In the past decade, several endocrine treatment regimens have been developed for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, including tamoxifen,...

Adjuvant Anthracyclines in Breast Cancer: What Is Their Role?

Anthracyclines have been a mainstay of breast cancer therapy for decades, with strong evidence demonstrating their impact on breast cancer survival. However, concerns regarding rare but serious long-t...

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.

More From BioPortfolio on "Exemestane or Anastrozole in Treating Postmenopausal Women With Hormone Receptor-Positive Primary Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial