580 Participants Needed

Combination Therapies for Breast Cancer

(Morpheus-panBC Trial)

Recruiting at 32 trial locations
RS
RS
Overseen ByReference Study ID Number: CO40115 https://forpatients.roche.com/
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as investigational therapies, biologic treatments, and systemic immunosuppressive medications, at least 2 weeks prior to the study. It's best to discuss your specific medications with the study team to see if they are allowed.

Is the combination therapy for breast cancer generally safe for humans?

Research shows that eribulin and capecitabine, when used in combination with other treatments, are generally well-tolerated in breast cancer patients, with minimal side effects like myelosuppression (low blood cell counts) and alopecia (hair loss).12345

What makes this drug combination unique for breast cancer treatment?

This combination therapy is unique because it includes atezolizumab, an immunotherapy drug that targets PD-L1, and is the first of its kind approved for advanced triple-negative breast cancer when used with nab-paclitaxel. This approach leverages the immune system to fight cancer, offering a novel mechanism compared to traditional chemotherapy.56789

What data supports the effectiveness of the drug combination therapies for breast cancer?

The combination of atezolizumab (Tecentriq) with nab-paclitaxel has shown to significantly prolong progression-free survival in patients with advanced triple-negative breast cancer, according to the phase III IMpassion130 trial. This suggests that the combination therapy can be effective in treating this type of breast cancer.3681011

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with metastatic or locally advanced breast cancer, including those who haven't had systemic therapy for TNBC, have progressed after first-line chemo, or have HR+/HER2- disease with PIK3CA mutation. Participants must be able to take capecitabine and agree to contraception if of childbearing potential. They should not have received certain prior treatments and must meet specific health criteria.

Inclusion Criteria

I haven't had any systemic treatment for my advanced triple-negative breast cancer.
My cancer is HER2 positive or low, and my blood sugar levels are within normal limits.
Your blood sugar levels are within a certain range when fasting and your HbA1c level is not too high.
See 24 more

Exclusion Criteria

I do not meet the exclusion criteria for Stage 1.
You have or had a condition where your immune system attacks your own body, or your immune system doesn't work properly.
Eligibility only for the control arm
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants are assigned to one of several treatment arms based on their cohort and receive treatment until unacceptable toxicity or disease progression

Variable, based on individual response
Regular visits as per treatment cycle (21 or 28 days)

Treatment Stage 2

Participants in the 2L CIT-naïve cohort who experience disease progression or loss of clinical benefit during Stage 1 may continue treatment with a different combination

Variable, based on individual response

Follow-up

Participants are monitored for safety and effectiveness after treatment

120 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Bevacizumab
  • Capecitabine
  • Gemcitabine + Carboplatin or Eribulin
  • Ipatasertib
  • Nab-Paclitaxel
  • Sacituzumab Govitecan
  • Selicrelumab
  • SGN-LIV1A
  • Tocilizumab
Trial Overview The study tests various treatment combinations (chemotherapy, targeted drugs like Inavolisib and Ribociclib, immunotherapies such as Atezolizumab) in four different patient cohorts based on their type of breast cancer and previous treatments. It's a two-stage trial where patients may switch treatments if they don't benefit from the initial one.
How Is the Trial Designed?
16Treatment groups
Experimental Treatment
Active Control
Group I: Inavolisib + Ribociclib (dose #2) + LetrozoleExperimental Treatment3 Interventions
Group II: Inavolisib + Ribociclib (dose #2) + FulvestrantExperimental Treatment3 Interventions
Group III: Inavolisib + Ribociclib (dose #1) + LetrozoleExperimental Treatment3 Interventions
Group IV: Inavolisib + Ribociclib (dose #1) + FulvestrantExperimental Treatment2 Interventions
Group V: Inavolisib + Abemaciclib + LetrozoleExperimental Treatment2 Interventions
Group VI: Inavolisib + Abemaciclib + FulvestrantExperimental Treatment3 Interventions
Group VII: Inavolisib (dose #2) + Trastuzumab DeruxtecanExperimental Treatment1 Intervention
Group VIII: Inavolisib (dose #1) + Trastuzumab DeruxtecanExperimental Treatment2 Interventions
Group IX: Atezolizumab + Selicrelumab + BevacizumabExperimental Treatment3 Interventions
Group X: Atezolizumab + Sacituzumab GovitecanExperimental Treatment2 Interventions
Group XI: Atezolizumab + SGN-LIV1AExperimental Treatment2 Interventions
Group XII: Atezolizumab + Nab-Paclitaxel + TocilizumabExperimental Treatment3 Interventions
Group XIII: Atezolizumab + IpatasertibExperimental Treatment2 Interventions
Group XIV: Atezolizumab + Chemo (Gemcitabine + Carboplatin or Eribulin)Experimental Treatment2 Interventions
Group XV: CapecitabineActive Control1 Intervention
Group XVI: Atezolizumab + Nab-PaclitaxelActive Control2 Interventions

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecentriq for:
🇪🇺
Approved in European Union as Tecentriq for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Seagen Inc.

Industry Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

In a study of 29 patients with HER2-positive operable breast cancer, the combination of nab-paclitaxel and trastuzumab followed by FEC resulted in a high pathological complete response (pCR) rate of 74.0%, indicating strong efficacy in the neoadjuvant chemotherapy setting.
The treatment was generally well tolerated, with sensory neuropathy being the most common side effect; however, severe grade 3 neuropathy occurred in only 3.4% of patients, suggesting a favorable safety profile.
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial.Tokunaga, S., Takashima, T., Kashiwagi, S., et al.[2019]
In a study involving 58 patients with recurrent HER2-negative breast cancer, eribulin showed a median progression-free survival (PFS) of 6.6 months compared to 4.2 months for treatment of physician's choice (TPC), suggesting a potential benefit in delaying disease progression.
Although eribulin demonstrated improved median time to treatment failure (TTF) of 6.0 months versus 3.6 months for TPC, these differences were not statistically significant, indicating that further studies are necessary to confirm the efficacy of eribulin in this setting.
Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19).Aogi, K., Watanabe, K., Kitada, M., et al.[2022]
Atezolizumab, combined with nab-paclitaxel, significantly improved progression-free survival in patients with advanced triple-negative breast cancer (TNBC) compared to placebo, based on the phase III IMpassion130 trial involving patients with unresectable locally advanced or metastatic TNBC.
While the combination therapy showed a tolerable safety profile, with common side effects like neutropenia and immune-related adverse events, it did not significantly affect health-related quality of life for patients.
Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer.Kang, C., Syed, YY.[2020]

Citations

Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial. [2019]
Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19). [2022]
Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. [2020]
Paclitaxel combination therapy in the treatment of metastatic breast cancer: a review. [2015]
Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. [2021]
Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer. [2015]
Future options with capecitabine (Xeloda) in (neo)adjuvant treatment of breast cancer. [2019]
Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD). [2021]
Efficacy and toxicity of Trastuzumab and Paclitaxel plus Capecitabine in the first-line treatment of HER2-positive metastatic breast cancer. [2021]
Atezolizumab-induced hemolytic anemia - A case report. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
New directions with capecitabine combinations in advanced breast cancer. [2015]
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