20 Participants Needed

Chemotherapy + Trastuzumab for Early-Stage HER2 Positive Breast Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug combination of chemotherapy and trastuzumab for early-stage HER2-positive breast cancer?

Research shows that trastuzumab, when combined with chemotherapy, improves survival and clinical outcomes in patients with HER2-positive breast cancer. This combination is considered the standard of care for both early and metastatic stages of the disease.12345

Is the combination of chemotherapy and trastuzumab safe for early-stage HER2-positive breast cancer?

The combination of chemotherapy and trastuzumab for early-stage HER2-positive breast cancer has been studied for safety, particularly regarding heart health. Some studies report a risk of heart-related side effects, but these treatments are generally well-tolerated with careful monitoring.678910

How is the drug combination of chemotherapy and trastuzumab unique for early-stage HER2-positive breast cancer?

The combination of chemotherapy and trastuzumab is unique because it targets HER2-positive breast cancer by using trastuzumab, a drug that specifically binds to the HER2 protein on cancer cells, along with chemotherapy to enhance the treatment's effectiveness. This approach is different from using chemotherapy alone, as trastuzumab helps improve survival rates and quality of life by specifically targeting cancer cells with minimal additional toxicity.12346

Research Team

AY

Amulya Yellala, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for women with stage I-II HER2/neu positive breast cancer post-surgery. Participants must have normal organ function, not be pregnant or nursing, agree to use birth control, and have no history of severe illnesses or conditions that could interfere with the study.

Inclusion Criteria

Your alkaline phosphatase level should not be more than 1.5 times the upper limit of normal within 30 days before joining the trial.
Your total bilirubin level has to be within a certain range in the last 30 days before joining the study.
Your liver function tests should not be more than 1.5 times the upper limit of normal within the last 30 days before joining the trial.
See 11 more

Exclusion Criteria

I have had cancer before, but it was either skin cancer treated successfully or a non-spreading type.
Pregnant or nursing women
I am able to follow the treatment plan as directed.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Systemic Therapy

Patients receive cyclophosphamide, paclitaxel, and trastuzumab intravenously on day 1, repeated every 14 days for 6 courses

12 weeks
6 visits (in-person)

Maintenance Trastuzumab Therapy

Patients receive trastuzumab intravenously every 21 days for up to 52 weeks

52 weeks
Approximately 17 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Every 3 months

Treatment Details

Interventions

  • Cyclophosphamide
  • Paclitaxel
  • Trastuzumab
Trial Overview The effectiveness and side effects of cyclophosphamide, paclitaxel, and trastuzumab are being tested after surgery in patients with early-stage HER2-positive breast cancer. The goal is to prevent cancer recurrence by using these chemotherapy drugs and a monoclonal antibody.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, paclitaxel, trastuzumab)Experimental Treatment4 Interventions
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Trastuzumab (Herceptin) combined with endocrine therapy is a promising treatment for women with less aggressive, estrogen receptor/HER2-positive metastatic breast cancer, while for aggressive HER2-positive cases, it significantly improves survival when used with chemotherapy, particularly taxanes.
Trastuzumab has a favorable safety profile, adding little toxicity to taxane chemotherapy, and enhances quality of life compared to chemotherapy alone, making it a viable option for patients who may not tolerate cytotoxic treatments.
Maximizing clinical benefit with trastuzumab.Bell, R., Verma, S., Untch, M., et al.[2019]
In a study of 210 patients with ERBB2-positive metastatic breast cancer, the combination of trastuzumab and pertuzumab without chemotherapy showed a 24-month overall survival rate of 79.0%, which is comparable to 78.1% for those receiving the combination with chemotherapy.
Patients receiving the chemotherapy-free regimen had a median progression-free survival of 8.4 months, significantly shorter than the 23.3 months for those who received chemotherapy, but the absence of chemotherapy resulted in fewer adverse events and slight improvements in quality of life.
Pertuzumab Plus Trastuzumab With or Without Chemotherapy Followed by Emtansine in ERBB2-Positive Metastatic Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial.Huober, J., Weder, P., Ribi, K., et al.[2023]
Trastuzumab (Herceptin) has demonstrated significant antitumor activity in patients with HER-2-positive metastatic breast cancer, improving response and survival rates when combined with first-line chemotherapy.
Recent clinical trials have focused on new chemotherapy approaches for node-positive breast cancer, laying the groundwork for ongoing studies that incorporate trastuzumab into treatment regimens.
Ongoing and planned adjuvant trials with trastuzumab.Perez, EA., Hortobagyi, GN.[2015]

References

Maximizing clinical benefit with trastuzumab. [2019]
Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer: final results of the Retreatment after HErceptin Adjuvant trial. [2022]
Pertuzumab Plus Trastuzumab With or Without Chemotherapy Followed by Emtansine in ERBB2-Positive Metastatic Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. [2023]
Ongoing and planned adjuvant trials with trastuzumab. [2015]
Adjuvant trastuzumab in HER2-positive breast cancer. [2022]
Cardiac safety of neoadjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel/pertuzumab/trastuzumab for HER2-positive breast cancer patients. [2021]
Cardiac Safety of Dual Anti-HER2 Therapy in the Neoadjuvant Setting for Treatment of HER2-Positive Breast Cancer. [2018]
Adjuvant trastuzumab and vinorelbine for early-stage HER2+ breast cancer. [2023]
Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. [2022]
Trastuzumab in the adjuvant treatment of breast cancer. [2016]
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