Study on Chemotherapy with Trastuzumab and Pertuzumab for HER2-Negative Breast Cancer with Abnormal HER2 Signaling

Sponsor: NSABP Foundation Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03412643

Provider View

This clinical trial is testing a combination of chemotherapy and targeted therapy drugs, trastuzumab and pertuzumab, in patients with HER2-negative breast cancer that shows abnormal HER2 signaling. The study aims to see if this treatment can improve outcomes compared to standard chemotherapy alone.

Patient Parameters

Program Overview

This study is designed to evaluate if adding trastuzumab and pertuzumab to chemotherapy can help patients with HER2-negative breast cancer that has abnormal HER2 signaling. Before starting treatment, patients will undergo a biopsy to check their HER2 signaling status. Those with abnormal signaling will receive a combination of weekly paclitaxel and the targeted therapies trastuzumab and pertuzumab, after initial treatment with doxorubicin and cyclophosphamide. The main goal is to see if this approach leads to a higher rate of complete cancer response in the breast and lymph nodes compared to historical data. The study will also look at other outcomes like tumor response and the relationship between HER2 signaling and treatment success. Approximately 270 patients will be screened to enroll 54 eligible participants.

Description

Patients will first have a biopsy to check their HER2 signaling activity. If the test shows abnormal HER2 signaling, they will receive a treatment plan that includes weekly paclitaxel and the targeted therapies trastuzumab and pertuzumab, following initial chemotherapy with doxorubicin and cyclophosphamide. The study's main goal is to determine if this treatment combination can lead to a higher rate of complete cancer response in the breast and lymph nodes compared to standard chemotherapy alone. Secondary goals include evaluating the complete response in the breast, clinical response, and the relationship between HER2 signaling and treatment outcomes. The study aims to enroll 54 patients with abnormal HER2 signaling from an initial screening of about 270 patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of invasive breast cancer by core needle biopsy.
  • The breast tumor must be at least 2 cm in size and palpable.
  • Lymph nodes can be classified as cN0, cN1, or cN2a.
  • Tumor must be histological grade II or III.
  • Lymph nodes must be evaluated by imaging within 6 weeks before starting chemotherapy.
  • Tumor must be HER2-negative based on specific testing criteria.
  • Blood counts and liver function tests must meet specific criteria.
  • Must have adequate heart function with an LVEF of at least 55%.
  • Must agree to use effective non-hormonal contraception during and after treatment.
  • Tumor must show abnormal HER2 signaling based on CELx HSF test.

Exclusion Criteria

  • Have T4 tumors or inflammatory breast cancer.
  • Diagnosis made by FNA alone.
  • Have had excisional biopsy or lumpectomy before starting chemotherapy.
  • Have had surgical axillary staging before starting chemotherapy.
  • Have evidence of metastatic disease.
  • Have synchronous bilateral invasive breast cancer.
  • Have a history of ipsilateral invasive breast cancer or DCIS.
  • Have had previous therapy with anthracycline, taxanes, trastuzumab, or other HER2 therapies.
  • Have used sex hormonal therapy recently.
  • Have had non-breast malignancies within 2 years.
  • Have cardiac disease that prevents use of study drugs.
  • Have uncontrolled high blood pressure.
  • Have active hepatitis B or C.
  • Have poorly controlled diabetes.
  • Have active or chronic infections.
  • Be HIV positive.
  • Have significant nervous system disorders.
  • Have gastrointestinal conditions affecting function.
  • Have other systemic diseases preventing treatment.
  • Be on chronic corticosteroid treatment.
  • Have known allergies to study drugs.
  • Be pregnant or breastfeeding.
  • Have psychiatric or addictive disorders affecting study participation.

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