HER2-Targeted Therapy for Breast Cancer

Recruiting at 192 trial locations

Overseen By Jack Beranek

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: HER2-targeted therapy

Must not be taking: Investigational anti-cancer agents

Disqualifiers: Stage IV cancer, Inadequate cardiac function, others

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

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

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

Compensation: Varies

Number of Visits: 27

Duration: 6-12 months

1524 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether 6 months of targeted treatment is as effective as 12 months for individuals with HER2-positive breast cancer. Participants who had a complete response after pre-surgery chemotherapy, meaning no invasive cancer was found, are eligible. The treatments, trastuzumab and pertuzumab, aim to stop cancer cell growth by blocking the HER2 protein. Ideal participants are those who had successful pre-surgery treatment for HER2-positive breast cancer and currently have no invasive disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use investigational anti-cancer agents at the time of registration, and if you previously took certain breast cancer endocrine therapies, they must have been stopped more than 12 months before joining the trial.

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

Research has shown that the combination of pertuzumab and trastuzumab has been tested in previous studies. In these studies, serious side effects occurred in about 62% to 63% of patients. Common side effects include fatigue, nausea, and low white blood cell counts, which can lead to infections. However, the FDA has approved these treatments for HER2-positive breast cancer, indicating they are generally considered safe when used correctly. Each person's experience may vary, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, pertuzumab and trastuzumab, because they specifically target the HER2 protein, which is overexpressed in some breast cancers. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, these drugs are designed to target cancer cells more precisely, potentially reducing side effects. The option of administering these drugs intravenously (IV) or subcutaneously (SC) offers flexibility and convenience for patients. Additionally, the trial is investigating different durations of treatment, which could lead to more personalized therapy plans.

What evidence suggests that this trial's treatments could be effective for HER2+ breast cancer?

This trial will evaluate the effectiveness of pertuzumab and trastuzumab in treating HER2-positive breast cancer. Studies have shown that using these drugs together can significantly aid in treating this cancer type. This combination has increased survival rates and slowed cancer growth. In one study, patients who received this treatment lived for a median of 57.1 months. The treatment targets and blocks HER2, a protein that promotes cancer cell growth, and marks these cells for destruction by the immune system. Research supports that this approach effectively extends life and improves outcomes for patients with HER2-positive breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Adrienne Waks, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

This trial is for men and women with HER2+ breast cancer who had no invasive disease left after pre-surgery chemo with trastuzumab. They must have clinical stage T1c-T3, N0-N1 (except T3N1), ECOG status 0-2, received specific neoadjuvant therapy durations, and can't have isolated tumor cells in nodes.

Inclusion Criteria

Both of my breasts had invasive cancer and both met the study's requirements, including HER2+.

I completed at least 12 weeks of chemo with trastuzumab, possibly with pertuzumab, before surgery.

My breast cancer is at a specific stage and has not spread extensively to lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trastuzumab and possibly pertuzumab every 21 days for up to 17 cycles (12 months) or 9 cycles (6 months), depending on the arm

6-12 months

Every 21 days

Follow-up

Participants are monitored for recurrence-free survival and quality of life, with follow-ups every 6 months for 5 years, then annually up to 10 years

10 years

Every 6 months for 5 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Pertuzumab
• Trastuzumab

Trial Overview The study compares two durations of HER2-targeted therapy: a shorter 6-month course versus the standard 12-month course after surgery. It aims to see if the shorter treatment works just as well for those who responded completely to initial chemo plus trastuzumab.

How Is the Trial Designed?

Group I: Arm 2 (6-month adjuvant therapy) Experimental Treatment 9 Interventions

Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

Group II: Arm 1 (12-month adjuvant therapy) Active Control 9 Interventions

Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4022699/

Pertuzumab in Combination with Trastuzumab and ... HER2-overexpressing breast cancer cell lines demonstrate a decreased overall survival when given both trastuzumab and pertuzumab but have limited, if any, ...

2. asco.org asco.org/about-asco/press-center/news-releases/trastuzumab-deruxtecan-pertuzumab-destiny-breast09

Trastuzumab Deruxtecan With Pertuzumab May Delay ... The combination of trastuzumab deruxtecan (Enhertu®) with pertuzumab (Perjeta®) can delay cancer growth for longer than the current standard of care.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2789454

Comparative Effectiveness and Safety of Pertuzumab ... End-of-study analyses of the CLEOPATRA trial found median overall survival (OS) of 57.1 months in patients receiving pertuzumab compared with ...

4. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2025/enhertu-combination-improved-pfs-in-1l-her-positive-mbc.html

Enhertu plus pertuzumab demonstrated highly statistically ... Enhertu plus pertuzumab demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival vs. THP ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1413513

Pertuzumab, Trastuzumab, and Docetaxel in HER2 ... First-line therapy with pertuzumab, trastuzumab, and docetaxel significantly improved overall survival among patients with HER2-positive ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41160818/

Trastuzumab Deruxtecan plus Pertuzumab for HER2- ... The incidence of grade 3 or higher adverse events was 63.5% with trastuzumab deruxtecan plus pertuzumab and 62.3% with THP; the most common were ...

7. nature.com nature.com/articles/s41523-023-00587-2

Pertuzumab plus high-dose trastuzumab for HER2-positive ... We report final efficacy data after a further 21-months of follow-up, updated safety, survival, and patient-reported outcomes (PROs). Patients ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12506-0

Safety and efficacy analysis of neoadjuvant pertuzumab ... The aim of the NeoPower study was to collect and analyze the data of patients with HER2 + early breast cancer (eBC) treated in the neoadjuvant ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1526820925001077

Long-Term Safety and Efficacy of the Fixed-Dose ... Immature efficacy data showed high event-free rates for IDFS and OS at 3 years, which were consistent with the known clinical benefit of P + H, (although follow ...