A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study of Atezolizumab With or Without Entinostat in Patients with Advanced Triple Negative Breast Cancer, with a Phase 1b Lead in Phase [SNDX-275-0602]
Clinical Trial Information
Trial Contact: Morales, Leticia; Pelley, Jennifer; Jobson, Gillian S
IRB No: WIRB 1168723
Protocol Abbrev: TRIO 025
Principal Investigator: Rebecca L. Moroose, MD
Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Rostorfer, Regan MD; Shah, Nikita MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: SNDX-275-0602
Applicable Disease Sites: Breast Cancer
Therapies Involved: atezolizumab and entinostat
ClinicalTrials.gov ID: NCT02708680
Phase 2 (Expansion Cohort): To perform an evaluation of the efficacy of entinostat at the RP2D in combination with atezolizumab in patients with aTNBC, as determined by the duration of progression-free survival.
1. Females aged 18 years or older on the day written informed consent is given.
2. Has histologically or cytologically confirmed triple negative breast carcinoma that is either metastatic (stage IV of the TNM classification) or locally recurrent and not amenable to local curative treatment. Disease must also be amenable to core biopsy (image-guided if applicable) at enrollment and for certain cohorts as described in the protocol, at least once during study treatment. TNBC diagnosis should be based on local ER/PgR/HER-2 laboratory results.
3. Evidence of measurable (according to RECIST version 1.1) locally recurrent or metastatic disease based on imaging studies (e.g., CT, MRI) within 28 days before the first dose of study drug.
4. Has received at least 1, but no more than 2, prior lines of systemic therapy for locally recurrent and/or metastatic disease
5. If patient has a history of treated asymptomatic CNS metastases they are eligible, provided they meet all of the following criteria:
Patient has measurable disease outside CNS;
• Patient does not have metastases to midbrain, pons, medulla or spinal cord;
• Patient is not on corticosteroids as therapy for CNS disease (anticonvulsants at a stable dose are allowed);
• Patient has not had whole-brain radiation within 6 weeks prior to study enrollment;
• Patient has stable CNS disease as demonstrated by at least 4 weeks of stability between the last intervention scan and the study screening scan.
6. ECOG performance status of 0 or 1.3
7. Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to ≤Grade 1 (except alopecia or neuropathy). If patient underwent major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention.