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triple-negative Breast Cancer

GeparDouze (GBG 96)

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

Erkrankung: Brustkrebs (Mammakarzinom) Invas. duktales Karzinom
Status der Studie: Studie rekrutiert
Studiendesign: interventionell
Studienphase: Phase III
Studienart: Medikamentöse Therapie
Haupteinschlusskritieren: 1. The patient must have consented to participate and, prior to beginning
specific study procedures, must have signed and dated an appropriate IRBapproved
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 (see Section 6.0).
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. (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.)
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  18 years old.
7. Patient may be female or male.
8. The ECOG performance status must be 0-1
Hauptausschlusskritieren: 1. Excisional biopsy or lumpectomy performed prior to study entry.
2. FNA alone to diagnose the breast cancer.
3. 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.
4. Definitive clinical or radiologic evidence of metastatic disease.
5. Previous history of contralateral invasive breast cancer. (Patients with
synchronous and/or previous contralateral DCIS or LCIS are eligible.)
6. Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS.
(Patients with synchronous or previous ipsilateral LCIS are eligible.)
7. 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.
8. Treatment including radiation therapy, chemotherapy, or targeted therapy,
for the currently diagnosed breast cancer prior to randomization.
9. Previous therapy with anthracyclines or taxanes for any malignancy.
Prüfarzt: Dr. med. Antje Lehnert

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