Atezolizumab + Sacituzumab for Breast Cancer

Recruiting at 8 trial locations

Overseen By Elizabeth A Mittendorf, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Strong UGT1A1 inhibitors

Disqualifiers: Metastatic disease, Active infection, Cardiovascular disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Duration: 18 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, atezolizumab (an immunotherapy drug) and sacituzumab govitecan (an antibody-drug conjugate), to determine their effectiveness in treating breast cancer that persists after chemotherapy and surgery. The researchers aim to discover if these drugs can help when cancer cells remain in the breast or lymph nodes, particularly if tumor DNA is detected in the blood. Suitable candidates for this trial are those who have tested negative for HER2, ER, and PR in their breast cancer tests and have completed surgery and chemotherapy. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take certain medications like strong UGT1A1 inhibitors or inducers, live vaccines, or systemic immunosuppressive medications close to the start of the study. It's best to discuss your current medications with the study team.

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

Research has shown that the combination of atezolizumab and sacituzumab govitecan is generally well-tolerated by patients with breast cancer. One study found that the safety of using these two drugs together is similar to using each one alone, meaning the side effects align with what doctors expect based on past use.

For sacituzumab govitecan, another study found it safe and effective when used alone in patients with metastatic triple-negative breast cancer (mTNBC). This finding provides some reassurance about its safety when combined with atezolizumab.

While side effects can occur, research suggests that most patients can manage both drugs. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Atezolizumab and Sacituzumab govitecan for breast cancer because this duo targets tumors in a novel way. Atezolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells, while Sacituzumab govitecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, minimizing damage to healthy cells. This combination could offer a more targeted approach compared to traditional chemotherapy, potentially improving effectiveness and reducing side effects.

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

Studies have shown that sacituzumab govitecan effectively treats advanced triple-negative breast cancer, particularly in patients who have tried other treatments. It delivers a drug that directly kills cancer cells. In this trial, participants will receive a combination of atezolizumab and sacituzumab govitecan. Research indicates that this combination can lead to positive results in patients with locally advanced or metastatic triple-negative breast cancer. This combination targets and attacks cancer cells while also helping the immune system recognize and fight the cancer. Evidence suggests this combo could be a promising option for tackling difficult cases of breast cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Elizabeth A Mittendorf, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HER2-negative, hormone receptor-negative breast cancer that remains after neoadjuvant chemotherapy and surgery. They must have circulating tumor DNA, be within 4 months post-treatment, and agree to use contraception. Exclusions include prior sacituzumab govitecan treatment, hypersensitivity to the drugs being tested, metastatic disease evidence, certain heart or lung conditions, active infections or other cancers within the last five years.

Inclusion Criteria

My blood and organs are functioning well.

I agree to use non-hormonal birth control during and for 6 months after my treatment.

I still have breast cancer in my breast or lymph nodes after chemotherapy.

Exclusion Criteria

I do not have an active autoimmune disease, except for controlled thyroid issues, celiac, psoriasis, eczema, lichen simplex chronicus, or vitiligo.

My cancer has spread to other parts of my body.

I have had breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Atezolizumab and Sacituzumab govitecan for 6 cycles (18 weeks)

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness every 6 months for 3 years

3 years

Bi-annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Sacituzumab govitecan

Trial Overview The ASPRIA trial tests whether combining Atezolizumab and Sacituzumab govitecan can prevent breast cancer recurrence in patients with residual disease post-chemotherapy who also have detectable circulating tumor DNA. It's an investigational study exploring this drug duo's effectiveness.

How Is the Trial Designed?

Group I: Atezolizumab and Sacituzumab govitecan Experimental Treatment 2 Interventions

Patients will receive the following treatment: Atezolizumab and Sacituzumab govitecan treatment will continue for 6 cycles (18 total weeks). * Atezolizumab intravenously (IV) at a pre-determined dose on day 1 in a 21-day cycle * Sacituzumab govitecan: intravenously (IV) at a pre-determined dose on days 1 and 8 in a 21-day cycle

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?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

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

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Published Research Related to This Trial

Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) in patients with endocrine-resistant HR+/HER2- metastatic breast cancer, showing a 34% reduction in the risk of progression or death compared to standard chemotherapy.

The safety profile of SG was manageable, with notable grade ≥ 3 adverse events including neutropenia and diarrhea, but it still represents a promising treatment option for patients with limited alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. Rugo, HS., Bardia, A., Marmé, F., et al.[2023]

In a phase 1/2 trial involving 108 patients with heavily pretreated metastatic triple-negative breast cancer, sacituzumab govitecan-hziy demonstrated a response rate of 33.3%, with a median duration of response of 7.7 months, indicating its efficacy in this challenging patient population.

The treatment was associated with significant myelotoxic effects, including anemia and neutropenia, but overall survival was promising at a median of 13.0 months, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. Bardia, A., Mayer, IA., Vahdat, LT., et al.[2019]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

In a phase 3 trial involving 543 patients with pretreated, endocrine-resistant HR+ and HER2- metastatic breast cancer, sacituzumab govitecan significantly improved overall survival compared to chemotherapy, with a median survival of 14.4 months versus 11.2 months.

Sacituzumab govitecan also showed a higher objective response rate (21% vs 14%) and better quality of life outcomes, indicating it is a promising new treatment option for patients with limited alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Rugo, HS., Bardia, A., Marmé, F., et al.[2023]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and delivers a topoisomerase I inhibitor, showing promise in treating metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies.

In April 2020, it received accelerated approval in the USA for mTNBC, and it is currently undergoing further clinical trials for various cancers, indicating its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. Syed, YY.[2021]

Sacituzumab govitecan (IMMU-132) has been shown to prolong progression-free survival in patients with advanced triple-negative breast cancer, indicating its efficacy as a treatment option.

The treatment is well tolerated, resulting in fewer and more manageable side effects compared to traditional irinotecan, suggesting a safer profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ADC for Triple-Negative Breast Cancer. [2018]

Sacituzumab govitecan (TRODELVY) is an effective treatment for metastatic triple-negative breast cancer, showing promising results in a phase I/II study and receiving accelerated FDA approval for patients who have undergone at least two prior therapies.

The drug has a well-defined and manageable toxicity profile, and proactive management of adverse events is crucial for optimizing treatment duration and maintaining patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer: Clinical Overview and Management of Potential Toxicities. Spring, LM., Nakajima, E., Hutchinson, J., et al.[2021]

Sacituzumab govitecan-hziy (TRODELVY) received accelerated FDA approval for treating metastatic triple-negative breast cancer (mTNBC) based on a trial involving 108 patients, showing an objective response rate of 33.3% and a median duration of response of 7.7 months.

The safety profile was assessed in a larger group of 408 patients, with common side effects including nausea, neutropenia, and fatigue, occurring in 25% or more of patients, indicating that while effective, the treatment can have significant adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. Wahby, S., Fashoyin-Aje, L., Osgood, CL., et al.[2022]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511734

Sacituzumab Govitecan in Untreated, Advanced Triple- ... Here, we report the primary results from the ASCENT-03 trial of sacituzumab govitecan as compared with chemotherapy for the first-line treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452463/

Real-world use patterns, effectiveness, and tolerability of ... Sacituzumab govitecan (SG), a Trop-2–directed antibody–drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04434040

NCT04434040 | Atezolizumab + Sacituzumab Govitecan to ... The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in ...

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01177-9/fulltext

Effectiveness of sacituzumab govitecan and management ... This study highlights the real-world effectiveness and safety of SG as 2L+ treatment for mTNBC. •. Survival benefit and TTNTD with SG were ...

5. onclive.com onclive.com/view/frontline-atezolizumab-plus-sacituzumab-govitecan-elicits-responses-in-pd-l1-advanced-tnbc

Frontline Atezolizumab Plus Sacituzumab Govitecan Elicits ... First-line atezolizumab plus sacituzumab govitecan led to responses in PD-L1–positive locally advanced or metastatic triple-negative breast cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10542232/

Safety and effectiveness of sacituzumab govitecan in ... We report real-world safety and effectiveness in patients with mTNBC receiving sacituzumab govitecan treatment at a breast cancer centre in Germany.

7. esmoopen.com esmoopen.com/article/S2059-7029(24)00971-2/fulltext

181O Interim analysis (IA) of the atezolizumab (atezo) + ... PFS data were immature but showed a trend towards benefit with atezo + SG. Safety of atezo + SG was consistent with the profiles of the individual drugs, with ...