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Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer
Phase 1, PHASE2 trial testing Atezolizumab in Stage III Breast Cancer in 12 participants. Terminated before completion.
| Lead sponsor | Vanderbilt-Ingram Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 10 July 2018 |
| Primary completion | 10 December 2020 |
| Estimated completion | 10 December 2020 |
| Sites | 1 location across United States |
Vanderbilt-Ingram Cancer Center — full company profile →
18 and older, female only, with Stage III Breast Cancer or Stage IIIA Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessment of DLT for the patients in the atezolizumab and idasanutiln arm of the study
| Group | Value | 95% CI |
|---|---|---|
| Phase 1b - (Atezolizumab, Idasanutlin) | 1 |
Assessment of MTD for the atezolizumab and idasanutiln combination arm of the study
| Group | Value | 95% CI |
|---|---|---|
| Phase 1b - (Atezolizumab, Idasanutlin) | NA |
Assessment of recommended phase II dose for the atezolizumab and idasanutiln combination arm of the study
| Group | Value | 95% CI |
|---|---|---|
| Phase 1b - (Atezolizumab, Idasanutlin) | NA |
Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER \+ breast cancer by measure the rate (%) of complete and partial responses seen in patients with measurable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Phase 2 (Atezolizumab, Cobimetinib) | NA | NA – NA |
Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER \+ breast cancer by measure the rate (%) of complete and partial responses + stability of disease at 6 months seen in patients with measurable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Phase 2 (Atezolizumab, Cobimetinib) | NA | NA – NA |
Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER \+ breast cancer by measuring the interval (in months) between treatment initiation and disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).
| Group | Value | 95% CI |
|---|---|---|
| Phase 2 (Atezolizumab, Cobimetinib) | 56 | 51 – NA |
Assessment of clinical impact (anti-tumor effect) of the combination of atezolizumab and cobimetinib or idasanutiln in patients with metastatic ER \+ breast cancer by measuring the interval (in months) between treatment initiation and death from any cause
| Group | Value | 95% CI |
|---|---|---|
| Phase 2 (Atezolizumab, Cobimetinib) | 161 | 136 – NA |
Assessment of adverse events throughout the phase II study
| Group | Value | 95% CI |
|---|---|---|
| Phase 2 (Atezolizumab, Cobimetinib) | 99 |
Time frame: Initiation of study medication, throughout the study, and within 28 days (+/- 7 days) of the last dose of study medication, for a total of 2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 2 (Atezolizumab, Cob… | Phase 1b - (Atezolizumab, … |
|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Platelet count decrease | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Suicide | Psychiatric disorders | — | — |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | — | — |
| Strep infection | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Death | Investigations | — | — |
| Reaction | System | Phase 2 (Atezolizumab, Cob… | Phase 1b - (Atezolizumab, … |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Hypokalemia | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Blurred vison | Eye disorders | — | — |
| Hepatic pain | Hepatobiliary disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
| Esophagitis | Gastrointestinal disorders | — | — |
| Gingival pain | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Neutrophil count decreased, Febrile neutropenia, Platelet count decrease, Arthralgia, Back pain, Suicide, Osteonecrosis, Strep infection.
Data from ClinicalTrials.gov NCT03566485 adverse events section.
This phase I/II trial studies the side effects and best dose of idasanutlin when given together with atezolizumab, and to see how well atezolizumab and cobimetinib or idasanutlin work in treating participants with stage IV estrogen-receptor positive (ER+) breast cancer, or ER+ breast cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib and idasanutlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib or atezolizumab with idasanutlin may work better in treating participants with estrogen-receptor positive breast cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03566485.
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