Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

404

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started May 2012

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

14 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.6 years study duration

Study Start

First participant enrolled

May 5, 2012

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2012

Completed

11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed

12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed

Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

12.6 years

First QC Date

May 27, 2012

Last Update Submit

November 26, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

RFS
RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer
after a follow up of 5 years
DDFS
DDFS events includes distant metastasis due to breast cancer
after a follow up of 5 years
BCSS
BCSS events includes death for breast cancer
after a follow up of 5 years

Secondary Outcomes (1)

adverse reaction
during the period of trial (up to 7 years)

Study Arms (3)

PEPI：2-4 group-A

EXPERIMENTAL

Drug: AI+chemotherapy adjuvant therapy

PEPI：2-4 group-B

ACTIVE COMPARATOR

Drug: AI adjuvant therapy

PEPI：0-1group

ACTIVE COMPARATOR

Drug: AI adjuvant therapy

Interventions

AI adjuvant therapyDRUG

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

PEPI：0-1group

AI+chemotherapy adjuvant therapyDRUG

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

PEPI：2-4 group-A

Eligibility Criteria

AgeUp to 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Tao OUYANGlead

Study Sites (14)

Peking Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

301 Hospital of Pla