Clinical Trials /

Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients

NCT02532400

Description:

To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian suppression with chemotherapy in premenopausal patients with hormone receptor-positive breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients
  • Official Title: Comparison of Neoadjuvant Aromatase Inhibitors With Ovarian Suppression Versus Chemotherapy in Premenopausal Patients With Hormone Receptor-positive Breast Cancer (COMPETE): a Randomized Phase 3 Trial

Clinical Trial IDs

  • ORG STUDY ID: RJBC1505
  • NCT ID: NCT02532400

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Neoadjuvant endocrine therapyGoserelin and AINeoadjuvant endocrine therapy
Neoadjuvant chemotherapyTECNeoadjuvant chemotherapy

Purpose

To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian suppression with chemotherapy in premenopausal patients with hormone receptor-positive breast cancer.

Detailed Description

      Neoadjuvant therapy is nowadays the standard treatment for both early stage and locally
      advanced breast cancer, and exhibited similar benefit compared with adjuvant therapy in terms
      of disease free and overall survival. Patients achieved pathological complete response(pCR)
      after neoadjuvant chemotherapy have superior outcome compared with those with residual tumors
      in breast and/or axilla. pCR is now the most wildly accepted surrogate marker for long-term
      survival of patients, especially in those with triple negative or human epidermal growth
      factor receptor-2(HER2)-positive breast cancer. However, in luminal HER2-negative breast
      cancer, neoadjuvant chemotherapy is not as effective as in other subtypes of breast cancer,
      pCR is less noted and seems barely correlated to long-term survival benefit.

      In postmenopausal patients with hormone receptor-positive breast cancer, neoadjuvant
      endocrine therapy of aromatase inhibitor achieved similar clinical response rate compared
      with neoadjuvant chemotherapy, and in premenopausal hormone receptor-positive, HER2-negative
      breast cancer patients, neoadjuvant aromatase inhibitor plus ovarian function
      suppression(OFS) has showed more pronounced efficacy than tamoxifen plus OFS.

      In adjuvant setting, aromatase inhibitor combined with OFS in premenopausal patients with
      hormone receptor-positive breast cancer has demonstrated superior benefit in terms of disease
      free survival, and has been established as one of the routine options of adjuvant endocrine
      therapy. Notwithstanding the remarkable performance of combination of aromatase inhibitor and
      OFS in adjuvant therapy, the role of this treatment strategy in neoadjuvant setting has yet
      not been proved when compared with neoadjuvant chemotherapy.

      The aim of this study is to prospectively compare the efficacy and safety of neoadjuvant
      aromatase inhibitor plus OFS with chemotherapy in premenopausal patients with hormone
      receptor-positive HER2-negative breast cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant endocrine therapyExperimentalSix months of exemestane or anastrozole plus goserelin.
  • Neoadjuvant endocrine therapy
Neoadjuvant chemotherapyActive ComparatorSix cycles of docetaxel plus epirubicin and cyclophosphamide(TEC).
  • Neoadjuvant chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent

          2. Women aged ≥ 18 years

          3. Histologically confirmed invasive breast cancer

          4. American Joint Committee on Cancer (AJCC) stage: ⅡA-ⅢC, no evidence of metastasis

          5. At least one measurable disease in breast and/or axilla

          6. ER and/or progesterone receptor(PgR) positive(≥10% of the cells by IHC)

          7. HER2 negative(by IHC and/or FISH)

          8. Premenopause status (estradiol in premenopausal range or with normal menstrual cycle
             in the past 6 months with no use of hormonal drugs)

          9. Eastern Cooperative Oncology Group(ECOG)score 0-1, an estimated life expectancy of at
             least 12 months

         10. Adequate bone marrow function: Leukocyte ≥ 3.0*109/L; Neutrophil ≥ 1.5*109/L; Hb ≥
             100g/L; Platelet(PLT) ≥ 80*109/L

         11. Adequate liver, renal function and coagulation function: Alanine transaminase(ALT)
             and/or Aspartate transaminase(AST)≤ 1.5 upper normal limit(UNL), total bilirubin
             ≤upper normal limit, creatinine ≤ 110umol/L, Creatinine clearance > 60ml/min, blood
             urea nitrogen(BUN) ≤ 7.1mmol/L, activated partial thromboplastin time(APTT) ≤ 1.5
             upper normal limit(UNL)

         12. Women with child-bearing potential must have a negative pregnancy test (urine or
             serum) within 7 days of drug administration and agree to use an acceptable method of
             birth control to avoid pregnancy for the duration of the study

         13. Serological records of hepatitis B virus(HBV)and hepatitis C virus(HCV) testing.

        Exclusion Criteria:

          1. Stage IV breast cancer

          2. Prior systemic or loco-regional treatment of breast cancer

          3. Any anti-neoplastic treatment within 28 days before the beginning of study

          4. Known severe hypersensitivity to any drugs in this study

          5. History of malignancy within 5 years except carcinoma in situ of cervix or skin basal
             cell carcinoma that had received adequate treatment

          6. Peripheral neuropathy ≥ 2°, according to National Cancer Institute(NCI) Common
             Terminology Criteria for Adverse Events(CTCAE)(Version 4.0)

          7. Any cardiac or pulmonary dysfunction defined as following:

        (1) ≥ 3° symptomatic congestive heart failure (CHF) according to NCI CTCAE(Version 4.0) or
        ≥ 2° CHF according to New York Heart Association(NYHA)

        (2) Angina that needs anti-anginal drugs, advanced conduction abnormality or significant
        vascular disease

        (3) Uncontrolled high-risk arrhythmia: atrial tachycardia that silent heart rate >100/min,
        significant ventricular arrythmia or advanced atrioventricular block(2° type II
        atrioventricular or 3° atrioventricular block)

        (4) Poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)

        (5) Transmural myocardial infarction in EKG

        (6) Long-term oxygen therapy

        8. Uncontrolled severe systemic disease(clinically significant cardiovascular
        disease,pulmonary disease or metabolic disease, wound healing disorder, ulcer, severe
        infection)

        9. Pregnant or breast feeding

        10. Major operation, obvious trauma within 28 days before randomization or planned major
        operation during the study

        11. Known active hepatic disease due to hepatitis B virus, hepatitis C virus, auto-immune
        liver disease or sclerosing cholangitis

        12. Known HIV infection

        13. Any reasons investigators consider that not suitable for the study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate(ORR)
Time Frame:up to 7 months
Safety Issue:
Description:Overall response rate(ORR) is defined as complete response rate plus partial response rate.

Secondary Outcome Measures

Measure:Pathological complete response(pCR)
Time Frame:up to 7 months
Safety Issue:
Description:
Measure:Breast conserving surgery(BCS) rate
Time Frame:up to 7 months
Safety Issue:
Description:
Measure:Incidence of neutropenia fever
Time Frame:participants will be followed during the six months of neoadjuvant therapy
Safety Issue:
Description:
Measure:Incidence of hot flushes/flashes
Time Frame:participants will be followed during the six months of neoadjuvant therapy
Safety Issue:
Description:
Measure:Incidence of osteoporosis
Time Frame:participants will be followed during the six months of neoadjuvant therapy
Safety Issue:
Description:
Measure:Incidence of grade 3-4 adverse events
Time Frame:participants will be followed during the six months of neoadjuvant therapy
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ruijin Hospital

Trial Keywords

  • Breast Neoplasms
  • Neoadjuvant Endocrine Therapy
  • Ovarian Function Suppression
  • Neoadjuvant chemotherapy

Last Updated

April 10, 2017