Chemotherapy + Atezolizumab for Breast Cancer

Not currently recruiting at 223 trial locations

Overseen By Director, Department of Site and Study Management

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NSABP Foundation Inc

Must not be taking: Anthracyclines, Taxanes, Immunosuppressants, others

Disqualifiers: Metastatic disease, Cardiac disease, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding atezolizumab (Tecentriq), an experimental drug, to standard chemotherapy before surgery can more effectively reduce tumor size and prevent breast cancer recurrence post-surgery. It targets individuals with triple-negative breast cancer, where cancer cells lack certain receptors. Participants must have a diagnosis of triple-negative breast cancer that impacts daily life through symptoms or treatment needs. The study also seeks to understand the side effects of atezolizumab when combined with standard chemotherapy. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it does exclude those on certain treatments like systemic immunosuppressive medications and therapeutic anti-coagulants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that atezolizumab, the experimental drug in this study, generally has a manageable safety profile for patients. While some side effects occur, they are usually not severe and can be treated. Atezolizumab is also used for other types of cancer, which provides some confidence about its safety.

In previous studies, patients treated with atezolizumab showed encouraging results in fighting tumors. It's important to remember that, like any treatment, side effects can occur. However, data so far suggests that the benefits might outweigh these risks for many patients. Those considering joining a trial should discuss potential side effects and benefits with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Atezolizumab for breast cancer because it works differently from standard treatments like chemotherapy or hormone therapy. Atezolizumab is an immunotherapy, meaning it helps the body's immune system recognize and attack cancer cells, which is a different approach than simply targeting the cancer cells directly. This treatment is administered through an IV infusion and is designed to be used alongside chemotherapy, potentially enhancing the overall effectiveness and offering hope for better outcomes in breast cancer treatment.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research shows that atezolizumab, one of the treatments studied in this trial, may effectively treat early-stage triple-negative breast cancer when combined with chemotherapy. Studies have found that long-term outcomes, such as event-free survival (the time patients remain free from certain negative health events), generally improve for patients receiving atezolizumab. In one study, patients treated with atezolizumab had better survival rates than those who only received chemotherapy, with a 24% lower risk of negative events for those taking atezolizumab. However, adding atezolizumab can also increase the likelihood of certain side effects. Participants in this trial may receive either atezolizumab or a placebo as part of their treatment regimen. ^{1 5 6 7 8}

Who Is on the Research Team?

Norman Wolmark, MD

Principal Investigator

NSBP Foundation, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with triple-negative breast cancer who haven't had certain treatments yet. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have normal organ function. Women must not be pregnant or breastfeeding and agree to contraception if of childbearing potential.

Inclusion Criteria

I am fully active or can carry out light work.

You have agreed to take part in the study and have signed a form that explains the study and how your information will be used. This includes giving a sample of your tumor for research purposes.

The patient must have consented to participate and signed an appropriate IRB-approved consent form

Exclusion Criteria

I have had breast cancer in the opposite breast before.

You have had a transplant using cells or organs from another person.

You have been diagnosed with HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy with atezolizumab or placebo, including paclitaxel and carboplatin followed by AC/EC

12 weeks

Weekly visits for paclitaxel and every 3 weeks for carboplatin

Surgery

Participants undergo surgery to remove the tumor

1 week

1 visit for surgery

Adjuvant Therapy

Participants receive adjuvant therapy with atezolizumab or placebo for approximately 6 months, potentially with concurrent radiation therapy

24 weeks

Every 3 weeks for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Placebo

Trial Overview The study tests whether adding Atezolizumab to standard pre-surgery chemotherapy is more effective than chemo with a placebo in shrinking tumors and preventing cancer return post-surgery. After surgery, patients may continue receiving Atezolizumab or placebo to further assess benefits.

How Is the Trial Designed?

Group I: Atezolizumab Experimental Treatment 1 Intervention

IV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose

Group II: Placebo Placebo Group 1 Intervention

IV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose

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

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

NSABP Foundation Inc

Lead Sponsor

Trials

89

Recruited

140,000+

Hoffmann-La Roche

Industry 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

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. Kang, C., Syed, YY.[2020]

The ASTEFANIA trial is designed to assess the effectiveness of combining atezolizumab, an immunotherapy, with ado-trastuzumab emtansine in treating high-risk, HER2-positive early breast cancer patients who have residual disease after initial HER2-targeted therapy.

This study will involve 1700 participants across 32 countries, focusing on invasive disease-free survival as the primary outcome, while also evaluating safety and pharmacokinetics, highlighting the potential for enhanced treatment strategies in early-stage breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. Hurvitz, SA., Bachelot, T., Bianchini, G., et al.[2022]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, combined with nab-paclitaxel, significantly improves progression-free survival and overall survival in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), as demonstrated in the IMpassion 130 trial.

The FDA and EMA approvals of atezolizumab represent a major advancement in treating metastatic TNBC, but further research is needed to identify better biomarkers for response and strategies to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the treatment of breast cancer. Reddy, SM., Carroll, E., Nanda, R.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12283416/

Peri-operative atezolizumab in early-stage triple-negative ... Long-term outcomes favored the atezolizumab group (event-free survival hazard ratio (HR), 0.76; 95% confidence interval (CI), 0.47–1.21; disease ...

2. targetedonc.com targetedonc.com/view/long-term-outcomes-bolstered-by-atezolizumab-in-early-stage-triple-negative-breast-cancer

Long-Term Outcomes Bolstered by Atezolizumab in Early- ... The latest analysis reveals that long-term outcomes consistently favored the atezolizumab group across all survival endpoints. While the trial ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/tecentriq-trial-post-surgery-triple-negative-breast-cancer

Tecentriq Falls Short in Phase III Trial in Post-Surgery ... Tecentriq (atezolizumab) added to postoperative chemotherapy was not found to improve treatment outcomes for patients with high-risk early-stage triple- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11783246/

Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer Compared with chemotherapy alone, atezolizumab plus chemotherapy was associated with more treatment-related grade 3 or 4 adverse events (54% vs ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2813177

Atezolizumab in Combination With Carboplatin and ... In this multicenter phase 2 randomized clinical trial, adding atezolizumab to carboplatin significantly increased PFS and OS in patients with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37921135/

Efficacy and Safety of Atezolizumab Monotherapy or ... Atezolizumab showed a manageable safety profile and had promising and durable anti-tumor efficacy in TMBC patients.

7. tecentriq.global tecentriq.global/home/indication/triple-negative-breast-cancer.html

Triple-negative breast cancer - tecentriq Significantly prolonged median PFS with TECENTRIQ in combination with nab-pac versus nab-pac alone (7.5 months vs 5.0 months; HR=0.62; 95% CI: 0.49, 0.78; p< ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2701722

Long-term Clinical Outcomes and Biomarker Analyses of ... Atezolizumab has demonstrated safety and durable long-term clinical benefit in a broad range of cancer types, including urothelial carcinoma and ...