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 (GeparDouze) - GeparDouze

SABP Foundation Inc.0 sites1,520 target enrollmentNovember 6, 2019

ConditionsPatients with early breast cancer MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTECENTRIQ??

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with early breast cancer
Sponsor: SABP Foundation Inc.
Enrollment: 1520
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 6, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

SABP Foundation Inc.

Eligibility Criteria

Inclusion Criteria

•1\. The patient must have consented to participate. 2\. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy. 3\. 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. 4\.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. Formalin\-fixed, paraffin\-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization for central confirmation of TNBC status and for correlative science studies. 5\. The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD\-L1 status using the Ventana PD\-L1 (SP142\) assay kit. Patients will be eligible irrespective of PD\-L1 testing result including PD\-L1 indeterminate. Patients will be classified as positive, negative, or indeterminate for stratification purposes. 6\. Patients must be \> or \= 18 years old. 7\. Patient may be female or male. 8\. The ECOG performance status must be 0\-1\. 9\. 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\. 10\. Ipsilateral axillary lymph nodes must be evaluated by imaging (ultrasound, and/or MRI) within 42 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. 11\.Patients with synchronous bilateral or multicentric HER2\-negative breast cancer are eligible as long as the highest risk tumor is ER\-negative and PgR\-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2\-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor. 12\. Blood counts performed within 28 days prior to randomization. 13\. Evidence of adequate hepatic function performed within 28 days prior to randomization.
•14\.Patients with AST or ALT or alkaline phosphatase \> ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET\-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion 13 are met. 15\. Patients with alkaline phosphatase that is \> ULN but \< or \= 2\.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET\-CT scan, or PET scan) supported by additional studies when indicated (CT, x\-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease. 16\.Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in criteria 14 and 15\) within 28 days prior to randomization. 17\. Creatinine clearance \> or \= 50 mL/min performed within 28 days prior to randomization. 18\.PT/INR \< or \= ULN within 28 days prior to randomization. For laboratories that do not report an ULN for the INR assay, use \< or \= 1\.2 as the value for the ULN. Patients receiving therapeutic anti\-coagulants are not eligible. 19\.A serum TSH and AM (morning) cortisol performed within 28 days prior

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.
•\- Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens.