A Randomized Trial, Phase IIIb, Open Label Study of Exemestane After Two to Three Years of Anastrozole/Letrozole Treatment of Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Fudan University1 site in 1 country540 target enrollmentMarch 2008

ConditionsBreast Cancer

Interventionsanastrozole letrozole exemestane

Drugsanastrozole letrozole exemestane

Overview

Phase: Phase 3
Intervention: anastrozole
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 540
Locations: 1
Primary Endpoint: disease free survival
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the rate of disease free survival (DFS) and distant disease free survival (DDFS) at 5 years in postmenopausal women with hormone receptor and lymph node positive breast cancer randomized between anastrozole/letrozole 5 years and anastrozole/letrozole 2-3 years switching to exemestane 3-2 years.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2011

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Fudan University

Eligibility Criteria

Inclusion Criteria

•Provision of written informed consent.
•Patient muse be female.
•Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
•A total mastectomy with institutional standard axillary nodal dissection.
•Lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation.
•Treatment of the breast cancer following diagnosis may have included any of the following; post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab.
•The tumor must have been pathologic primary invasive carcinoma by core needle or open biopsy.
•The beginning of endocrine therapy (letrozole or anastrozole) must be no more than 6 weeks from the end day of chemotherapy or radiotherapy.
•The date of randomization must be no less than 2 years of letrozole and no more than 3 years letrozole treatment.
•Positive node is defined as defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Criteria Edition

Exclusion Criteria

•Presence of metastatic disease.
•Previous diagnosis of metachronous bilateral breast cancer.
•Previous or concomitant other (non-breast cancer) malignance within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell.
•Presence of other non-malignant disease which may prevent prolonged follow-up.
•Received neoadjuvant endocrine therapy.
•Adjuvant SERMs therapy (Tamoxifen or Toremifene) for more than 6 months before randomization.
•Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
•Severe hepatic dysfunction defined as Child-Pugh grade C.
•Severe cardiac dysfunction defined above NYHA grade III.
•Presence of occult axillary lymph node with no evidence of primary breast tumor pathologically or DCIS with microinvasive. And the measurement of ER, PR and HER2 are not obtained.