Clinical Trials /

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

NCT02345772

Description:

Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
  • Official Title: Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study)

Clinical Trial IDs

  • ORG STUDY ID: WIRB 20140462
  • NCT ID: NCT02345772

Conditions

  • HER2-positive Breast Cancer
  • ER-positive Breast Cancer

Interventions

DrugSynonymsArms
fulvestrant 500 mgfulvestrantTreatment Protocol
DocetaxelTaxotereTreatment Protocol
Trastuzumab (H, 8mg/kgTrastuzumabTreatment Protocol
Pertuzumab (P, 840 mgPertuzumabTreatment Protocol

Purpose

Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.

Detailed Description

      Hormonal therapy with fulvestrant 500 mg to be administered before surgery With docetaxel,
      Trastuzumab, and pertuzumab to determine pathological complete remission rate at the time of
      surgery in ER-positive and HER2-positive patients with breast cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment ProtocolExperimentalHormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery. Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
  • fulvestrant 500 mg
  • Docetaxel
  • Trastuzumab (H, 8mg/kg
  • Pertuzumab (P, 840 mg

Eligibility Criteria

        Inclusion Criteria:

          1. Patients ≥ 18 years of age with histologically, and radiographically confirmed
             non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive
             (defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined
             by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size
             over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating
             physician

          2. Eastern Cooperative Oncology Group (ECOG) performance status score < 1

          3. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
             g/dL

          4. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5
             X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN
             (AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome)

          5. Women of child-bearing potential (i.e., women who are pre-menoposaul or not surgically
             sterile) must have a negative serum pregnancy test within 2 weeks prior to beginning
             treatment

        Exclusion Criteria:

          1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias

          2. LVEF (left ventricular ejection fraction) < 50% on any prior assessment. Note:
             Assessment of LVEF is done before and after trastuzumab-based chemotherapy as standard
             of care

          3. Pregnant or lactating females

          4. Inability to complete informed consent process and adhere to the protocol treatment
             plan and follow-up requirements

          5. Concurrent severe illness such as active infection, or psychiatric illness/social
             situations that would limit safety and compliance with study requirements
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological Complete Remission Rate
Time Frame:one year
Safety Issue:
Description:To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is;

Secondary Outcome Measures

Measure:Partial Pathological Response Rate
Time Frame:One Year
Safety Issue:
Description:Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b.
Measure:QTA (Quantitative Texture Analysis)
Time Frame:One year
Safety Issue:
Description:QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Western Regional Medical Center

Last Updated

December 29, 2017