Phase 2 N=120 Randomized Treatment

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00871858 ↗

Enrolled (actual)

120

Serious AEs

4.2%

Results posted

Feb 2021

Primary outcome: Primary: Objective Response Rate (ORR) Determined by Clinical Palpation — 58.9; 53.8 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: anastrozole (Drug); fulvestrant (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Institut Bergonié
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (ORR) Determined by Clinical Palpation	58.9; 53.8	—
SECONDARY Objective Response Rate (ORR) Determined by Ultrasound	35.1; 52.4	—
SECONDARY Objective Response Rate (ORR) Determined by Mammography	26.1; 27.8	—
SECONDARY Rate of Breast-conserving Surgery	60.7; 50.0	—
SECONDARY Percentage of Participants With 5-year Relapse-Free Survival	82.8; 74.7	—

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant. PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
SBR grade I-II disease (patients 65 years of age)
T2 (2-5 cm), T3, or T4B, and N0-1 disease
No metastatic disease
Breast lesion not amenable to breast-conserving resection
No inflammatory breast cancer
No prior breast cancer
Hormone receptor status:
Estrogen receptor- and/or progesterone receptor-positive

PATIENT CHARACTERISTICS:

Postmenopausal
No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix
No contraindication to anti-hormonal treatment
No psychological, familial, social, or geographical reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

At least 8 days since prior hormone replacement therapy
No concurrent anti-vitamin K treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00871858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.