Clinical Trials /

Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy

NCT01613560

Description:

This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study. The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant endocrinotherapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy
  • Official Title: Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy

Clinical Trial IDs

  • ORG STUDY ID: BCP08
  • NCT ID: NCT01613560

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
AI adjuvant therapyPEPI:0-1group
AI+chemotherapy adjuvant therapyPEPI:2-4 group-A
AI adjuvant therapyPEPI:2-4 group-B

Purpose

This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study. The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant endocrinotherapy.

Detailed Description

      In the decision-making process of a systemic adjuvant therapy for ER-positive/HER2-negative
      breast cancer, to avoid adjuvant chemotherapy is an attractive but hard choice. On one hand,
      the result of tamoxifen endocrine therapy combined with adjuvant chemotherapy is superior to
      tamoxifen endocrine therapy alone for ER-positive breast cancer patients; on the other hand,
      the benefit that adjuvant chemotherapy provides to breast cancer with high hormone receptor
      expression is not clear and the tolerance of chemotherapy is much lower than that of
      endocrinotherapy.

      St. Galen consensus on adjuvant therapy for early breast cancer recommends adopting simple
      endocrinotherapy and avoiding adjuvant chemotherapy for medium- and low- risk breast cancer
      with hormone receptor highly expressed. However, the results of study P024 and IMPACT suggest
      that hormone receptor expression is insufficient to predict the effect of endocrinotherapy.

      At present, the proven clinical value of neoadjuvant endocrinotherapy is to assist surgery.
      Consensus recommends neoadjuvant endocrinotherapy for the patients with postmenopausal breast
      cancer who plan to receive simple adjuvant endocrinotherapy. The current study results show
      that neoadjuvant endocrinotherapy may be used as an experimental treatment platform, i.e., it
      can predict the results of adjuvant endocrinotherapy through comprehensive analysis of
      multiple indexes of the surgery samples after neoadjuvant endocrinotherapy.

      By using P024 and IMPACT samples, Ellis et al studied the relation between survival and the
      test results of surgery samples after neoadjuvant endocrinotherapy, and obtained PEPI (the
      preoperative endocrine prognostic index). They have preliminarily proved that the PEPI score
      is relative to RFS (relapse-free survival) of postmenopausal ER-positive breast cancer
      treated with simple endocrinotherapy and to BCSS (breast cancer-specific survival).

      A retrospective study,performed by breast prevention and treatment center in Peking
      University Cancer Hospital,shows that RFS in PEPI score ≤ 1 group is superior to the PEPI > 1
      group after 16 weeks of neoadjuvant endocrinotherapy(p = 0.037), and RFS in effective group
      (Miller&Payne G1G2G3) is better than that in ineffective group (p=0.001) in terms of
      pathological evaluation.

      The objective of this study is to prospectively verify the relation of efficacy of
      neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary
      adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant
      endocrinotherapy.
    

Trial Arms

NameTypeDescriptionInterventions
PEPI:2-4 group-AExperimental
  • AI+chemotherapy adjuvant therapy
PEPI:2-4 group-BActive Comparator
  • AI adjuvant therapy
PEPI:0-1groupActive Comparator
  • AI adjuvant therapy

Eligibility Criteria

        Inclusion Criteria:

          -  Female, not more than 75 years old, judged to have been in menopause by the
             investigator when enrolled. Refer to the following criteria to determine whether they
             are postmenopausal breast cancer.

               -  Spontaneous amenorrhea for more than 12 months Age ≥ 60 Age < 60, but FSH and E2
                  reach postmenopausal level.

               -  Received bilateral ovariectomy previously

               -  Not to define the women using LHRH agonists or antagonists as in postmenopausal
                  state.

          -  Evidence of primary invasive breast cancer is confirmed by histopathological
             diagnosis.

          -  Clinical stage is T2-3N0M0

          -  ER or PgR are expressed in more than 50 percent of tumour cells, and HER2 is negative.

          -  No abnormal axillary nodes in ultrasound examination; no evidence of cancer metastasis
             confirmed by abnormal lymph node puncture pathological examination

          -  With plan of receiving simple endocrinotherapy and avoiding adjuvant chemotherapy

          -  No previous breast cancer treatment history

          -  No other tumors previously; no unstable complications or uncontrolled infection.

          -  No contraindication for endocrinotherapy with 3rd generation of aromatase inhibitors

          -  Participate in the trial voluntarily and sign the informed consent form.

        Exclusion Criteria:

          -  Evidence of distant breast cancer metastasis by pathological and imaging diagnosis

          -  Patients who have a history of other malignant tumors

          -  With contraindications for 3rd generation of aromatase inhibitors

          -  Physical condition can not bear the experiment

          -  Patients who have potential mental, psychological, familial, social, geographic, or
             other factors that can hinder study regime performance.

          -  Patients who were treated or are treated with other anti-tumor measures before or
             during this trial, or planed to participate in other clinical trials.

          -  Patients who refuse to participate in the trial.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:N/A
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:RFS
Time Frame:after a follow up of 5 years
Safety Issue:
Description:RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer

Secondary Outcome Measures

Measure:adverse reaction
Time Frame:during the period of trial (up to 7 years)
Safety Issue:
Description:incidence rate of Ⅲ or Ⅳ adverse reaction(according to NCI classification)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tao OUYANG

Last Updated

February 24, 2017