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

Breast Cancer Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01613560
• Other study ID #: BCP08
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 5, 2012
• Est. completion date: December 2024

Study information

• Verified date: November 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 404
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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
• AI adjuvant therapy
preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years

Locations

Country	Name	City	State
China	301 Hospital of Pla	Beijing	Beijing
China	307 Hospital of Pla	Beijing	Beijing
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Institution and Hospital.Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Cancer Hospital & Institute	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Shandong University	Jinan	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS	RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer	after a follow up of 5 years
Primary	DDFS	DDFS events includes distant metastasis due to breast cancer	after a follow up of 5 years
Primary	BCSS	BCSS events includes death for breast cancer	after a follow up of 5 years
Secondary	adverse reaction	incidence rate of ? or ? adverse reaction(according to NCI classification)	during the period of trial (up to 7 years)