EUCTR2017-002771-25-DE
Active, not recruiting
Phase 1
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 sites1,550 target enrollmentNovember 6, 2017
ConditionsPatients with early breast cancerMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)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
- 1550
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IEC\-approved consent form.
- •\- Diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
- •\- Pretreatment research core biopsy of the primary tumor must be performed with submission of 2 cores for required correlative studies.
- •\- 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.
- •\- Central testing for ER, PgR, HER2 and Ki\-67 will be performed, and the tumor must be determined to be ER\-negative, PgR\-negative, and HER2\-negative by current ASCO/CAP Guidelines Recommendations. Stromal TILs wil be evaluated in three groups: low immune infiltrate (0\-10% stromal TILs), intermediate immune infiltrate(11\-59% stromal TILs), LPBC (060\-100% stromal TILs. Material from either the diagnostic core biopsy or the research biopsy can be used for central testing depending on local preferences and standards.
- •\- Tumor specimen must also be used for central testing of PD\-L1 Status.
- •\- Patients must be \>\= 18 years old.
- •\- ECOG performance status must be 0\-1
- •\- 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\.
- •\- Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following 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.
- •\- Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens.
Outcomes
Primary Outcomes
Not specified
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