Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer

NCT00066378 | Completed Phase 2

• 2 other identifiers: EORTC-10021IDBBC-10021
• Study Type: interventional
• Target: 71
• Locations: 5 countries
• Sites: 9

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 1 year

  at 1 year

Secondary Outcomes (3)

• Tumor response as measured by RECIST

  from randomisation

• Duration of response as measured by RECIST

  response duration

• Safety as measured by CTC v2.0

  from randomization

Study Arms (2)

Arimidex + Iressa® 250 mg

EXPERIMENTAL

Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal

Drug: anastrozole; Drug: gefitinib

Arimidex + Placebo

ACTIVE COMPARATOR

Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal

Drug: anastrozole

Interventions

anastrozole DRUG

Arimidex + Iressa® 250 mg; Arimidex + Placebo

gefitinib DRUG

Arimidex + Iressa® 250 mg

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Radiologically or clinically evident metastatic or locally recurrent disease * Locally advanced disease in elderly patients * Bone metastases only allowed * Failed prior tamoxifen therapy * No rapidly progressive visceral metastases * No uncontrolled CNS metastases * Hormone receptor status: * Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age * Postmenopausal Sex * Female Menopausal status * Postmenopausal, defined by any of the following: * Natural menopause with last menses more than 1 year ago * Radiotherapy-induced oophorectomy with last menses more than 1 year ago * Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels clearly in the postmenopausal range * Surgical castration Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 2.5 times ULN * No unstable or uncompensated hepatic disease Renal * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease Pulmonary * No unstable or uncompensated pulmonary disease * No clinically active interstitial lung disease * Asymptomatic chronic stable radiographic changes are allowed Other * No severe or uncontrolled systemic disease * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or contralateral breast cancer * No psychological, familial, sociological or geographical condition that would preclude study compliance and follow-up * No grade 2 or greater unresolved chronic toxicity from prior anticancer therapy * No unresolved ocular inflammation or infection * No known hypersensitivity to anastrozole or gefitinib or any of their excipients PRIOR CONCURRENT THERAPY: Biologic therapy * No prior trastuzumab (Herceptin) * No concurrent biologic therapy Chemotherapy * No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting * No concurrent chemotherapy Endocrine therapy * At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) in the adjuvant setting * Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed * No prior aromatase inhibitors for metastatic disease * No other concurrent hormonal therapy Radiotherapy * No concurrent radiotherapy to any metastatic site Surgery * No surgery during and within 4 days after the last dose of gefitinib Other * At least 30 days since prior investigational drugs * No prior anti-epidermal growth factor therapy * No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase inhibitor receptor) * No concurrent administration of any of the following drugs: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St John's Wort) * No other concurrent investigational drugs or treatment * No other concurrent cancer treatment * No concurrent systemic retinoids * Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry * Bisphosphonates may be initiated during study only for the treatment of hypercalcemia

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (9)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, B-2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Institute of Oncology - Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (2)

• Mauriac L, Cameron D, Dirix L: Results of randomized phase II trial combining Iressa (gefitinib) and arimidex in women with advanced breast cancer (ABC): EORTC protocol 10021. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6133, 2008.

  RESULT

• Tryfonidis K, Basaran G, Bogaerts J, Debled M, Dirix L, Thery JC, Tjan-Heijnen VC, Van den Weyngaert D, Cufer T, Piccart M, Cameron D; EORTC-Breast Cancer Group. A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378). Eur J Cancer. 2016 Jan;53:144-54. doi: 10.1016/j.ejca.2015.10.012. Epub 2015 Dec 24.

  PMID: 26724641 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Gefitinib

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martine J. Piccart, MD, PhD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: May 1, 2003
• Primary Completion: August 1, 2007
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

NL (2); FR (2); SL (1); BE (3); GB (1)