A RANDOMIZED MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED COMPARISON OF CHEMOTHERAPY PLUS TRASTUZUMAB PLUS PLACEBO VERSUS CHEMOTHERAPY PLUS TRASTUZUMAB PLUS PERTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE PRIMARY BREAST CANCER

Not Applicable

• Registration Number: PER-092-11
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD., GENENTECH, INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-30
• Study Completion: 2019-06-12
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. AGE ≥ 18 YEARS.
2. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS ≤ 1.
3. NON-METASTATIC OPERABLE PRIMARY INVASIVE CARCINOMA OF THE BREAST THAT IS:
A) HISTOLOGICALLY CONFIRMED;
B) ADEQUATELY EXCISED:
• PATIENTS MUST HAVE UNDERGONE EITHER A TOTAL MASTECTOMY OR BREAST CONSERVING SURGERY.
• FOR PATIENS WHO UNDERGO CONSERVATIVE SURGERY, THE MARGINS OF THE RESECTED SPECIMEN MUST BE HISTOLOGICALLY FREE OF INVASIVE TUMOR AND DUCTAL CARCINOMA IN SITU (DCIS), AS DETERMINED BY THE LOCAL PATHOLOGIST. IF PATHOLOGIC EXAMINATION DEMONSTRATES TUMOR AT THE LINE OF RESECTION, ADDITIONAL OPERATIVE PROCEDURES MAY BE PERFORMED TO OBTAIN CLEAR MARGINS. IF TUMOR IS STILL PRESENT AT THE RESECTED MARGIN RE-EXCISION(S), THE PATIENT MUST UNDERGO TOTAL MASTECTOMY TO BE ELIGIBLE. PATIENTS WITH MARGINS POSITIVE FOR LOBULAR CARCINOMA IN SITU (LCIS) ARE ELIGIBLE WITHOUT ADDITIONAL RESECTION.
• FOR PATIENTS WHO UNDERGO MASTECTOMY, MARGINS MUST BE FREE OF GROSS RESIDUAL TUMOR. PATIENTS WITH MICROSCOPIC POSITIVE MARGINS ARE ELIGIBLE (SEE RADIATION THERAPY REQUIREMENTS).

Exclusion Criteria

1. HISTORY OF ANY PRIOR (IPSI- AND/OR CONTRALATERAL) INVASIVE BREAST CARCINOMA.
2. HISTORY OF NON-BREAST MALIGNANCIES WITHIN THE 5 YEARS PRIOR TO STUDY ENTRY, EXCEPT FOR THE FOLLOWING: CARCINOMA IN SITU OF THE CERVIX, CARCINOMA IN SITU OF THE COLON, MELANOMA IN SITU, AND BASAL CELL AND SQUAMOUS CELL CARCINOMAS OF THE SKIN (MALIGNANCIES OCCURRING MORE THAN 5 YEAR PRIOR TO STUDY ENTRY ARE PERMITTED IF CURATIVELY TREATED WITH SURGERY ALONE).
3. ANY CLINICAL T4 TUMOR AS DEFINED BY TNM, INCLUDING INFLAMMATORY BREAST CANCER.
4. ANY NODE-NEGATIVE TUMOR ≤ 0.5 CM REGARDLESS OF OTHER RISK FACTORS.
5. ANY PREVIOUS SYSTEMIC CHEMOTHERAPY (e.g., NEO-ADJUVANT OR ADJUVANT) OR CANCER OR RADIATION THERAPY FOR CANCER:
• PATIENT WITH A PAST HISTORY OF DCIS AND/OR LCIS ARE NOT ALLOWED TO ENTER THE STUDY IF THEY HAVE RECEIVED ANY FORM OF SYSTEMIC THERAPY FOR ITS TREATMENT; OR RADIATION THERAPY TO THE IPSILATERAL BREAST WHERE INVASIVE CANCER SUBSEQUENTLY DEVELOPS.
• PATIENTS WHO HAD THEIR DCIS/LCIS TREATED WITH SURGERY ONLY ARE ALLOWED TO ENTER THE STUDY.
• HIGH-RISK PATIENTS WHO HAVE RECEIVED CHEMOPREVENTION DRUGS IN THE PAST ARE NOT ALLOWED TO ENTER THE STUDY. 

Study & Design

• Study Type: Interventional
• Study Design: Not specified