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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Peking University
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT01613560
First received: May 27, 2012
Last updated: June 16, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Breast Cancer
Drug: AI adjuvant therapy
Drug: AI+chemotherapy adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • RFS [ Time Frame: after a follow up of 5 years ] [ Designated as safety issue: No ]
    RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer

  • DDFS [ Time Frame: after a follow up of 5 years ] [ Designated as safety issue: No ]
    DDFS events includes distant metastasis due to breast cancer

  • BCSS [ Time Frame: after a follow up of 5 years ] [ Designated as safety issue: No ]
    BCSS events includes death for breast cancer


Secondary Outcome Measures:
  • adverse reaction [ Time Frame: during the period of trial (up to 7 years) ] [ Designated as safety issue: Yes ]
    incidence rate of Ⅲ or Ⅳ adverse reaction(according to NCI classification)


Estimated Enrollment: 404
Study Start Date: June 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEPI:2-4 group-A Drug: AI+chemotherapy adjuvant therapy
preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years after adjuvant chemotherapy
Other Name: AI+chemotherapy adjuvant therapy
Active Comparator: PEPI:2-4 group-B Drug: AI adjuvant therapy
preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years
Other Name: AI adjuvant therapy
Active Comparator: PEPI:0-1group Drug: AI adjuvant therapy
preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years
Other Name: AI adjuvant therapy

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613560

Contacts
Contact: Tao Ouyang, Doctor 0086-10-88196695 ouyanghongtao@263.net

Locations
China, Beijing
Cancer Institution and Hospital.Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
Contact: XIANG WANG, M.D.         
Principal Investigator: XIANG WANG         
307 Hospital of Pla Recruiting
Beijing, Beijing, China
Contact: ZEFEI JIANG, M.D.         
Principal Investigator: ZEFEI JIANG, M.D.         
Beijing Chao-Yang Hospital Recruiting
Beijing, Beijing, China
Contact: HONGCHUAN JIANG, M.D.         
Principal Investigator: HONGCHUAN JIANG         
Beijing Hospital Recruiting
Beijing, Beijing, China
Contact: BO LI, M.D.         
Principal Investigator: BO LI, M.D.         
Peking Cancer Hospital & Institute Recruiting
Beijing, Beijing, China, 100142
Contact: TAO OUYANG         
Principal Investigator: TAO OUYANG, M.D.         
301 Hospital of Pla Recruiting
Beijing, Beijing, China
Contact: JIANDONG WANG, M.D.         
Principal Investigator: JIANDONG WANG, M.D.         
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: XUENING DUAN, M.D.         
Principal Investigator: XUENING DUAN, M.D.         
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
Contact: JIANGGUO ZHANG, M.D.         
Principal Investigator: JIANGUO ZHANG, M.D.         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: SHUDE CUI, M.D.         
Principal Investigator: SHUDE CUI, M.D.         
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: ZHIMIN FAN, M.D.         
Principal Investigator: ZHIMIN FAN, M.D.         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: FENG JIN, M.D.         
Principal Investigator: FENG JIN, M.D.         
China, Shandong
The Second Hospital of Shandong University Recruiting
Jinan, Shandong, China
Contact: ZHIGANG YU, M.D.         
Principal Investigator: ZHIGANG YU, M.D.         
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: KUNWEI SHEN, M.D.         
Principal Investigator: KUNWEI SHEN, M.D.         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: ZHIMIN SHAO, M.D.         
Principal Investigator: ZHIMIN SHAO, M.D.         
Sponsors and Collaborators
Tao OUYANG
Investigators
Study Chair: Tao Ouyang, Doctor Peking University Cancer Hospital Breast Center
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT01613560     History of Changes
Other Study ID Numbers: BCP08
Study First Received: May 27, 2012
Last Updated: June 16, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014