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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| AI adjuvant therapy | | PEPI：0-1group |
| AI+chemotherapy adjuvant therapy | | PEPI：2-4 group-A |
| AI adjuvant therapy | | PEPI：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
| Name | Type | Description | Interventions |
|---|
| PEPI：2-4 group-A | Experimental | | - AI+chemotherapy adjuvant therapy
|
| PEPI：2-4 group-B | Active Comparator | | |
| PEPI：0-1group | Active Comparator | | |
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: | Unknown status |
| Lead Sponsor: | Tao OUYANG |
Last Updated
January 18, 2019
