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Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo
 
Region Sponsors
California - Southern
NSABP Foundation Inc
 
Acronym KP IRB No.
11579
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) Diagnosis of Triple Negative Breast Cancer.
 
Purpose
The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery. Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.
 
Detailed Description
NSABP B-59/GBG 96-GeparDouze is a prospective, randomized, double-blind, Phase III clinical trial. This is a collaborative study being conducted by NSABP Foundation, Inc. in partnership with the German Breast Group (GBG), and supported by funding by Genentech, a Member of the Roche Group, and F. Hoffmann-La Roche, Ltd. In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated. Patients will then undergo surgery. Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively. Administration of radiation therapy will be based on local standards at the discretion of patients and investigators, but if administered, atezolizumab/placebo will be administered concurrently.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies
  • The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy
  • A pretreatment research core biopsy of the primary tumor must be performed with submission of 2 cores for required correlative studies. These specimens will NOT be returned to the site
  • Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)
  • Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations. Material from either the diagnostic core biopsy or the research biopsy can be used for central testing depending on local preferences and standards
  • The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • Excisional biopsy or lumpectomy performed prior to study entry. FNA alone to diagnose the breast cancer
  • Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited
  • Definitive clinical or radiologic evidence of metastatic disease
  • Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
  • Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry
  • Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization
  • Previous therapy with anthracyclines or taxanes for any malignancy
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation
  • Known allergy or hypersensitivity to the components of the doxorubicin, cyclophosphamide, carboplatin, or paclitaxel formulations
  • Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations

 
Keywords and/or Specific Medical Conditions
  • Triple Negative Breast Cancer
  • Neoplasms
  • Antineoplastic Agents
  • Neoplasms by Site
  • Atezolizumab
  • Skin Diseases
  • Breast Diseases
  • Triple Negative Breast Neoplasms
  • Breast Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Anaheim
  • Antelope MOB
  • Baldwin Park
  • Bellflower
  • Carlsbad
  • Edgemont MOB
  • Fontana
  • Garfield Specialty Center
  • Harbor City
  • Irvine
  • Lancaster MOB
  • Los Angeles (Sunset)
  • Panorama City
  • Pasadena
  • Riverside
  • San Diego
  • San Marcos
  • Southern California
  • Sunset-Vermont MOB
  • West LA
  • Woodland Hills
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Lara Durna, MD
Contact Information:
- Clinical.Trials@kp.org
-Pasadena


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