Pertuzumab + Trastuzumab + Chemotherapy for Advanced Breast Cancer

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Disqualifiers: Hepatitis B/C, HIV, Pregnancy, 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

Compensation: Varies

Number of Visits: 1

Duration: 18 weeks for LABC or until progression for MBC

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining two monoclonal antibodies, pertuzumab and trastuzumab, with the chemotherapy drug paclitaxel (in an albumin-stabilized nanoparticle formulation) to treat advanced HER2-positive breast cancer. The aim is to determine if these treatments can more effectively block tumor growth by preventing cancer cells from growing and spreading. Ideal participants are those diagnosed with stage II-IV HER2-positive breast cancer who have not received certain prior treatments for metastatic breast cancer. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

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

Research shows that the combination of pertuzumab, trastuzumab, and paclitaxel (in a special nanoparticle form) is generally well-tolerated by patients with HER2-positive breast cancer. Trastuzumab has been used successfully for many years and helps breast cancer patients live longer. When combined with trastuzumab, pertuzumab effectively stops cancer cells from growing.

The FDA has approved the use of pertuzumab and trastuzumab together for treating breast cancer, indicating their safety. Additionally, paclitaxel in its nanoparticle form is considered safe and effective, especially for more aggressive cancers.

While all treatments can have side effects, past studies have shown these to be manageable. Participants should discuss any concerns with their healthcare provider to understand the potential risks and benefits based on their personal health situation. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for breast cancer?

Researchers are excited about the combination of pertuzumab, trastuzumab, and nab-paclitaxel for advanced breast cancer because it targets cancer cells in a novel way. While standard treatments often rely on chemotherapy alone, this combination enhances effectiveness by using pertuzumab and trastuzumab, which are antibodies that specifically target HER2-positive cancer cells, leading to more precise attacks on tumors. Additionally, nab-paclitaxel, a nanoparticle formulation of paclitaxel, is designed to improve delivery and reduce some of the side effects associated with traditional chemotherapy. This multi-pronged approach aims to improve outcomes and offer a more targeted treatment option for patients with advanced breast cancer.

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

Research has shown that a combination of three drugs—pertuzumab, trastuzumab, and nab-paclitaxel—may effectively treat HER2-positive breast cancer. In this trial, participants will receive this combination treatment. Studies have found that trastuzumab and nab-paclitaxel work well together to slow or stop the growth of this cancer type. The FDA has approved pertuzumab with trastuzumab for early-stage HER2-positive breast cancer, indicating its effectiveness. This combination specifically targets cancer cells and can block their growth. Early research suggests that using all three drugs together might be a strong option for treating advanced breast cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Joanne Mortimer, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with HER2-positive advanced breast cancer who haven't had chemotherapy or trastuzumab for metastatic disease. They should have adequate blood counts, no serious medical conditions, and not be pregnant. Prior adjuvant therapy is allowed if it was over 12 months ago. Participants must agree to use contraception during the study.

Inclusion Criteria

You have not received chemotherapy or trastuzumab for metastatic breast cancer treatment before.

If you have metastatic breast cancer, you can participate if you had chemotherapy and trastuzumab more than 12 months ago.

Your white blood cell count is at least 3.0 billion cells per liter.

Exclusion Criteria

You have active hepatitis B or C.

You have nerve problems worse than mild.

Your heart's pumping ability was less than 50% during previous treatment with trastuzumab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation intravenously. Treatment repeats every 21 days for up to 6 courses for LABC or until disease progression for MBC.

18 weeks for LABC or until progression for MBC

Visits on days 1, 8, and 15 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 4 years, then every 6 months for 1 year.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel Albumin-Stabilized Nanoparticle Formulation
• Pertuzumab
• Trastuzumab

Trial Overview The trial tests how well a combination of pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation works in treating stage II-IV breast cancer by blocking tumor growth or killing tumor cells.

How Is the Trial Designed?

Group I: Treatment (pertuzumab, trastuzumab, nab-paclitaxel) Experimental Treatment 4 Interventions

Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01730833

Pertuzumab, Trastuzumab, and Paclitaxel Albumin ... This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150197/

The efficacy and safety of trastuzumab and albumin-bound ... This study explored the efficacy and safety of pyrotinib combined with trastuzumab and albumin-bound paclitaxel (nab-paclitaxel).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4959577/

Nab-paclitaxel and trastuzumab combination The nab-paclitaxel plus trastuzumab combination may be a valid option in the neoadjuvant treatment of HER2-positive breast cancer.

4. link.springer.com link.springer.com/article/10.1007/s12282-021-01238-9

Meta-analysis of nanoparticle albumin-bound paclitaxel ... We conducted a meta-analysis using individual patient data (IPD) to investigate the average efficacy of nab-PTX-containing regimens as ...

5. lbbc.org lbbc.org/news/fda-approves-combination-herceptin-and-perjeta-for-her2-positive-breast-cancer

FDA approves combination Herceptin and Perjeta for ... The FDA approved a new combination medicine, containing pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo), for treatment of early-stage and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4037302/

Pertuzumab in human epidermal growth-factor receptor 2 ... Trastuzumab (Herceptin), the first anti-HER2-targeted therapy, has been associated with improved survival outcomes in HER2-positive breast cancer. However, many ...

7. sigma.larvol.com sigma.larvol.com/product.php?e1=2889&tab=newstrac&page=39

Perjeta (pertuzumab) News The response to dual-targeted neoadjuvant therapy with trastuzumab and pertuzumab was adequate in hormone receptor-negative, HER-2-positive breast cancer ...