Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Trastuzumab deruxtecan

Bevacizumab

Atezolizumab

Carboplatin

Capecitabine

Hormones

Sacituzumab govitecan

Fulvestrant

Ipatasertib

Inavolisib

SGN-LIV1A

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immune Checkpoint Inhibitors

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Immunoconjugates

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Phosphoinositide-3 Kinase Inhibitors

1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab + nab-paclitaxel until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Enrollment is closed.

1L PD-L1-positive participants will receive combination treatment with atezolizumab plus nab-paclitaxel and tocilizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Enrollment is closed.

1L PD-L1-positive participants will receive doublet combination treatment with atezolizumab plus sacituzumab govitecan until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Enrollment is closed.

2L CIT-naive participants will receive capecitabine until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).

Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.

Enrollment is closed.

2L CIT-naive participants will receive doublet combination treatment with atezolizumab + ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.

Enrollment is closed.

2L CIT-naive participants will receive doublet combination treatment with atezolizumab plus SGNLIV1A until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.

Enrollment is closed.

2L-CIT-naive participants will receive doublet combination treatment with atezolizumab plus selicrelumab and bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Participants who progressed on treatment may have the option of receiving atezolizumab + chemo, provided they meet the eligibility criteria.

Enrollment is closed.

2L CIT-naive participants enrolled in the active comparator arm who experience disease progression per RECIST v1.1 and 2L CIT-naive participants enrolled in an experimental arm who experience loss of clinical benefit as determined by the investigator may receive doublet combination treatment with atezolizumab plus chemotherapy (gemcitabine + carboplatin or eribulin) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Enrollment is closed.

Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus abemaciclib plus fulvestrant until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Hormone receptor-positive (HR+) participants will receive treatment with inavolisib plus ribociclib plus fulvestrant until unacceptable toxicity or disease progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

HER2+/HER2-low participants will receive inavolisib (6 mg) + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

HER2+/HER2-low participants will receive inavolisib (9 mg) + trastuzumab deruxtecan until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.

Capecitabine will be administered 1250 mg/m\^2 orally twice daily on Days 1-14, of each 21 day cycle.

For Atezolizumab (Atezo) + SGN-LIV1A, Atezo + Sacituzumab Govitecan, or Atezo + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle.

For Atezo + Nab-Paclitaxel, Atezo + Selicrelumab + Bevacizumab, Atezo + Ipatasertib, or Atezo + Nab-Paclitaxel + Tocilizumab: atezolizumab will be administered IV, 840 mg on Days 1 and 15, of each 28-day cycle.

Ipatasertib will be administered by mouth 400 mg once a day, on Day 1-21 of each 28 day cycle.

SGN-LIV1A will be administered IV, 2.5 mg/kg (maximum calculated dose 250 mg), on Day 1 of each 21 day cycle.

Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28 day cycle.

Gemcitabine will be administered by IV, 1000 mg/m\^2, along with carboplatin, by IV, AUC 2, on Days 1 and 8 of each 21 day cycle.

Or

Eribulin will be administered by IV, 1.4 mg/m\^2 on days 1 and 8 of each 21 day cycle.

Chemotherapy (Gemcitabine + Carboplatin or Eribulin)

Selicrelumab will be administered by subcutaneous (SC) injection at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (cycle = 28 days).

Selicrelumab

Tocilizumab will be administered IV, 8 mg/kg infusion on Day 1 of each 28 day cycle.

Tocilizumab

Nab-Paclitaxel will be administered by IV, 100 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.

Nab-Paclitaxel

Sacituzumab govitecan will be administered by IV, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.

Sacituzumab Govitecan

Abemaciclib tablets will be administered at a dose of 150 mg twice daily by mouth on Days 1-28 of each cycle (cycle=28 days).

Abemaciclib

Fulvestrant IM injection at a dose of 500 mg will be administered on Days 1 and 15 of Cycle 1, and then on Day 1 of each cycle thereafter (cycle=28 days).

Ribociclib tablets of 400 mg will be administered by mouth on Days 1-21 of each 28-day cycle.

Ribociclib

Inavolisib tablets will be administered at a dose of 9 mg by mouth on Days 1-28 of each cycle (cycle = 28 days).

Inavolisib tablets will be administered at a dose of 9 mg by mouth on Days 1-21 of each cycle (cycle = 21 days).

Inavolisib (9 mg)

Inavolisib tablets will be administered at a dose of 6 mg by mouth on Days 1-21 of each cycle (cycle = 21 days).

Inavolisib (6 mg)

Trastuzumab Deruxtecan will be administered at a dose of 5.4 mg/kg by IV infusion on Day 1 of each 21-day cycle.

Trastuzumab Deruxtecan

Reference Study ID Number: CO40115 https://forpatients.roche.com/

Clinical Trials

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.

The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study:

Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort).

Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naive cohort).

Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort).

Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).

In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer	NCT03424005	Breast Cancer	Capecitabine Atezolizumab Ipatasertib SGN-LIV1A Bevacizumab Chemotherapy (G... Selicrelumab Tocilizumab Nab-Paclitaxel Sacituzumab Gov... Abemaciclib Fulvestrant Ribociclib Inavolisib Inavolisib (9 m... Inavolisib (6 m... Trastuzumab Der...	18 Years -	Hoffmann-La Roche
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer	NCT03424005	Breast Cancer	Capecitabine Atezolizumab Ipatasertib SGN-LIV1A Bevacizumab Chemotherapy (G... Selicrelumab Tocilizumab Nab-Paclitaxel Sacituzumab Gov... Abemaciclib Fulvestrant Ribociclib Inavolisib Inavolisib (9 m... Inavolisib (6 m... Trastuzumab Der...	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for inavolisib (6 mg)