ENDOCRINE THERAPY WITH OR WITHOUT ANTI-VEGF THERAPY: A RAMDOMIZED, PHASE III TRAIL OF ENDOCRINE THERAPY ALONE OR ENDOCRINE THERAPY PLUS BEVACIZUMAB (NSC 704865; IND 7921) FOR WOMEN WITH HORMONE RECEPTOR-POSITIVE ADVANCED BREAST CANCER

Not Applicable

• Registration Number: PER-010-11
• Lead Sponsor: GRUPO DE ESTUDIOS CLINICOS ONCOLOGICO DEL PERU GECOPERU, CANCER AND LEUKEMIA GROUP B (CALGB),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

ALL QUESTIONS TO CONSIDER THE SELECTION CRITERIA SHOULD BE DIRECTED TO STUDY CALGB ADDRESS: PLEASE NOTE THAT THE STUDY ADDRESS CAN NOT GRANT THE WAIVER ELIGIBILITY REQUIREMENTS.
4.1 DOCUMENTATION HISTOLOGIC: HISTOLOGIC CONFIRMATION INVASIVE BREAST CANCER FEMALE IN THE STADIUM PRIMARY OR METASTATIC.
4.1.1 STADIUM: DISEASE IN STAGE IV OR IIIB (USING THE CRITERIA AJCC 6TH EDITION) NO LOCAL THERAPY SENSITIVE.
4.2 PATIENT MAY NOT HAVE A MALIGNANT TUMOR CURRENT ASSETS THAN NON MELANOMA SKIN CANCER. PATIENTS ARE NOT CONSIDERED TO HAVE A MALIGNANT TUMOR CURRENT ASSETS IF THEY HAVE COMPLETED TERAPLA AND ARE CONSIDERED BY YOUR DOCTOR WITH LESS THAN 30% OF RISK OF RECURRENCE.
4.3 HORMONE RECEPTOR STATUS:
TUMORS (SITES BOTH PRIMARY AND METASTATIC) MUST STATE THE ESTROGEN RECEPTOR (ER) AND / OR PROGESTERONE (PgR) ≥ 1% POSITIVE CELL BE CONSIDERED.
4.4 AGE ≥ 18 YEARS.
4.5 STATUS MENOPAUSAL
4.5.1 POSTMENOPAUSAL WOMEN ARE ELIGIBLE FOR THIS TEST. PRIOR TO REGISTRATION STATUS TO STUDY TO BE DEFINED MENOPAUSAL TO THE CRITERIA DESCRIBED BELOW.
POSTMENOPAUSAL 4.5.2 ARE DEFINED AS:
• ≥ 55 YEARS OLD AND A YEAR OR MORE OF AMENORRHEA
• AGE <55 YEARS AND ONE YEAR OR MORE OF AMENORRHEA, ESTRADIOL WITH A TEST <20 pg / ml.
 

Exclusion Criteria

NO APLICABLE - ONLY IS CONSIDERED SELECTION CRITERIA

Study & Design

• Study Type: Interventional
• Study Design: Not specified