Trial Search Results

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

This trial includes a regimen of atezolizumab / placebo (double blind) in combination with neoadjuvant chemo (nab-paclitaxel followed by dose dense AC) for patients with TNBC. After definitive surgery, patients are unblinded. Patients who were on the atezolizumab arm receive 11 additional doses of atezo adjuvantly.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Intervention(s):

  • Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
  • Drug: Placebo
  • Drug: Nab-paclitaxel
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
  • Drug: Filgrastim
  • Drug: Pegfilgrastim

Phase:

Phase 3

Eligibility


Inclusion criteria:

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - Histologically documented TNBC (negative human epidermal growth factor receptor 2
   [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)

   - Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through
   central testing of a representative tumor tissue specimen

   - Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one
   radiographic or clinical measurement

   - Stage at presentation: cT2-cT4, cN0-cN3, cM0

   - Participant agreement to undergo appropriate surgical management including axillary
   lymph node surgery and partial or total mastectomy after completion of neoadjuvant
   treatment

   - Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>=) 53
   percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
   scans

   - Adequate hematologic and end-organ function

   - Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin
   blocks (preferred) or at least 20 unstained slides, with an associated pathology
   report documenting ER, PgR, and HER2 negativity

   - For women of childbearing potential: agreement to remain abstinent (refrain from
   heterosexual intercourse) or use contraceptive methods, and agreement to refrain from
   donating eggs

   - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
   contraceptive measures and agreement to refrain from donating sperm

   - Women who are not postmenopausal or have undergone a sterilization procedure must have
   a negative serum pregnancy test result within 14 days prior to initiation of study
   drug

Exclusion criteria:

   - Prior history of invasive breast cancer

   - Stage 4 (metastatic) breast cancer

   - Prior systemic therapy for treatment and prevention of breast cancer

   - Previous therapy with anthracyclines or taxanes for any malignancy

   - History of ductal carcinoma in situ (DCIS), except for participants treated
   exclusively with mastectomy >5 years prior to diagnosis of current breast cancer

   - History of pleomorphic lobular carcinoma in situ (LCIS), except for participants
   surgically managed >5 years prior to diagnosis of current breast cancer

   - Bilateral breast cancer

   - Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph
   nodes

   - Axillary lymph node dissection prior to initiation of neoadjuvant therapy

   - History of other malignancy within 5 years prior to screening, with the exception of
   those with a negligible risk of metastasis or death

   - Cardiopulmonary dysfunction

   - 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 formulations of
   atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or
   pegfilgrastim

   - Active or history of autoimmune disease or immune deficiency diseases except history
   of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and
   dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or
   vitiligo (e.g., participants with psoriatic arthritis are excluded)

   - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
   pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
   chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
   field (fibrosis) is permitted

   - Positive human immunodeficiency virus (HIV) test at screening

   - Active hepatitis B and hepatitis C virus infection

   - Active tuberculosis

   - Severe infections within 4 weeks prior to initiation of study treatment, including but
   not limited to hospitalization for complications of infection, bacteremia, or severe
   pneumonia

   - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
   of study treatment, except prophylactic antibiotics

   - Major surgical procedure within 4 weeks prior to initiation of study treatment or
   anticipation of need for a major surgical procedure during the course of the study

   - Prior allogeneic stem cell or solid organ transplantation

   - Administration of a live attenuated vaccine within 4 weeks prior to initiation of
   study treatment or anticipation of need for such a vaccine during the study

   - Any other disease, metabolic dysfunction, physical examination finding, or clinical
   laboratory finding giving reasonable suspicion of a disease or condition that
   contraindicates the use of an investigational drug or that may affect the
   interpretation of the results or render the participant at high risk from treatment
   complications

   - Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
   checkpoint-blockade therapies, including anti-cluster of differentiation 40
   (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4),
   anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies

   - Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
   drug, whichever is longer, prior to initiation of study treatment

   - Treatment with systemic immunosuppressive medications within 2 weeks prior to
   initiation of study treatment or anticipation of need for systemic immunosuppressive
   medications during the study

   - History of cerebrovascular accident within 12 months prior to randomization

   - Pregnant or lactating, or intending to become pregnant during the study

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kaitlin Zablotsky
650-725-2142
Not Recruiting