Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Trastuzumab

Everolimus

Atezolizumab

Ipatasertib

Palbociclib

Pertuzumab

Inavolisib

Antineoplastic Agents, Immunological

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Immune Checkpoint Inhibitors

Phosphoinositide-3 Kinase Inhibitors

30 milligrams (mg) orally once a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

Giredestrant

150 mg orally twice a day (during each 28-day cycle or 21-day cycle, depending on the regimen) until unacceptable toxicity or disease progression

Abemaciclib

400 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

9 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

600 mg orally once a day on Days 1-21 of each 28-day cycle until unacceptable toxicity or disease progression

Ribociclib

10 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

360 mg orally once a day during each 28-day cycle until unacceptable toxicity or disease progression

Samuraciclib

On Day 1 of Cycle 1 (1 cycle is 21 days), pertuzumab and trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) will be administered SC as a fixed dose formulation of 1200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase. On Day 1 of Cycles 2 and beyond, PH FDC SC will be administered SC once every 21 days as a fixed dose of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase.

PH FDC SC

125 mg orally once a day on Days 1-21 during each 28-day cycle until unacceptable toxicity or disease progression

840 mg by intravenous (IV) infusion on Days 1 and 15 each 28-day cycle.

Reference Study ID Number: CO42867 https://forpatients.roche.com/

Clinical Trials

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER-positive, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib or neratinib). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. During Stage 1, participants in each cohort will be randomly assigned to treatment arms. Participants in the control or experimental arms who experience unacceptable toxicity, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator during Stage 1 will be given the option of receiving a different treatment combination during Stage 2, provided they meet eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is currently available.

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER)

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer	NCT04802759	Inoperable, Loc...	Giredestrant Abemaciclib Ipatasertib Inavolisib Ribociclib Everolimus Samuraciclib PH FDC SC Palbociclib Atezolizumab	18 Years -	Hoffmann-La Roche
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer	NCT04802759	Inoperable, Loc...	Giredestrant Abemaciclib Ipatasertib Inavolisib Ribociclib Everolimus Samuraciclib PH FDC SC Palbociclib Atezolizumab	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for ph fdc sc

Every month we try and update this database with for ph fdc sc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ph fdc sc

Every month we try and update this database with for ph fdc sc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ph fdc sc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.