CHEMOTHERAPY STUDY WITH PREMENOPAUSIC ENDOCRINE RESPONSE (PERCHE), A PHASE III TRIAL EVALUATING THE ROLE OF CHEMOTHERAPY AS ADJUVANT THERAPY FOR PREMENOPAUSIC WOMEN WITH BREAST CANCER WITH ENDOCRINE RESPONSE WHO RECEIVE ENDOCRINE THERAPY.

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-070-03
• Lead Sponsor: INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-01-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Histologically confirmed breast cancer confined to the breast and axillary nodes
• Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease:
• Breast-conserving surgery (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive cancer and ductal carcinoma in situ) followed by radiotherapy NOTE: *If all other margins are clear, a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed
• Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes
• Total mastectomy with or without adjuvant radiotherapy
• Inflammatory breast cancer
• Supraclavicular node involvement
• Enlarged internal mammary nodes (unless pathologically negative)
• Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria
• Patient must be Premenopausal, Female
• Fertile patients must use effective nonhormonal contraception

Exclusion Criteria

• No distant metastatic disease
• No locally advanced, inoperable breast cancer, including any of the following characteristics:
• No prior ipsilateral or contralateral invasive breast cancer
• No prior deep venous thrombosis and/or embolism unless patient is medically suitable
• No systemic cardiovascular disease that would preclude prolonged follow-up
• No systemic pulmonary disease that would preclude prolonged follow-up
• Not pregnant or nursing
• No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ without invasion, contralateral or ipsilateral carcinoma in situ of the breast
• No prior or concurrent nonbreast invasive malignancy within the past 5 years that is nonrecurrent

Study & Design

• Study Type: Interventional
• Study Design: Not specified