Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

NCT00871858 | Completed Phase 2 Results

• 2 other identifiers: CDR00006333292007-004216-31
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Determined by Clinical Palpation

  Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

  6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR) Determined by Ultrasound

  6 months

• Objective Response Rate (ORR) Determined by Mammography

  6 months

• Rate of Breast-conserving Surgery

  6 months

• Percentage of Participants With 5-year Relapse-Free Survival

  5 years

Study Arms (2)

Arm A (ANA)

ACTIVE COMPARATOR

Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.

Drug: anastrozole

Arm B (FULV)

EXPERIMENTAL

Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.

Drug: fulvestrant

Interventions

anastrozole DRUG

Given orally

Arm A (ANA)

fulvestrant DRUG

Given intramuscularly

Arm B (FULV)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer, meeting 1 of the following criteria: * SBR grade I-II disease (patients \< 65 years of age) * SBR grade I-III 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

Related Publications (2)

• Quenel-Tueux N, Debled M, Rudewicz J, MacGrogan G, Pulido M, Mauriac L, Dalenc F, Bachelot T, Lortal B, Breton-Callu C, Madranges N, de Lara CT, Fournier M, Bonnefoi H, Soueidan H, Nikolski M, Gros A, Daly C, Wood H, Rabbitts P, Iggo R. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer. Br J Cancer. 2015 Aug 11;113(4):585-94. doi: 10.1038/bjc.2015.247. Epub 2015 Jul 14.

  PMID: 26171933 RESULT

• Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pelissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

  PMID: 32001832 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Nathalie Quenel-Tueux
• Organization: Institut Bergonié, Medical Oncology department

N.Quenel-Tueux@bordeaux.unicancer.fr

05.56.33.33.33

Study Officials

• Louis Mauriac, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 18, 2008
• Primary Completion: November 30, 2013
• Study Completion: July 2, 2018
• Last Updated: February 24, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-02

Locations

FR (1)