Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

NCT00099437 | Active Not Recruiting Phase 3 Results

• 2 other identifiers: D6997C000022004-002371-16
• Study Type: interventional
• Target: 736
• Locations: 17 countries
• Sites: 106

Brief Summary

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Conditions

Breast Cancer

Keywords

Advanced Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP)

  Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

  RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

• Clinical Benefit Rate (CBR)

  Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

• Duration of Response (DoR)

  RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

• Duration of Clinical Benefit (DoCB)

  RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

• Overall Survival (OS)

  Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)

Study Arms (2)

1

EXPERIMENTAL

Fulvestrant 500 mg

Drug: Fulvestrant

2

EXPERIMENTAL

Fulvestrant 250 mg

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

intramuscular injection

Also known as: Faslodex, ZD9238

1; 2

Eligibility Criteria

• Age: 45 Years - 130 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
• Requiring hormonal treatment
• Postmenopausal women defined as a woman who has stopped having menstrual periods
• Evidence of positive estrogen receptor hormone sensitivity
• Written informed consent to participate in the trial

You may not qualify if:

• Treatment with an investigational or non-approved drug within one month
• An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
• A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
• Treatment with more than one regimen of chemotherapy for advanced breast cancer
• Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (106)

Research Site

Casa Grande, Arizona, 85122, United States

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Fountain Valley, California, 92708, United States

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New Britain, Connecticut, 06052, United States

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Crystal River, Florida, 34429, United States

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Fort Lauderdale, Florida, 33308, United States

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Urbana, Illinois, 61801, United States

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Rosedale, Maryland, 21237, United States

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Detroit, Michigan, 48202, United States

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Kansas City, Missouri, 64131, United States

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St Louis, Missouri, 63141, United States

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Voorhees Township, New Jersey, 08043, United States

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Greenville, North Carolina, 27858, United States

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Pasadena, Texas, 77504, United States

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West Bend, Wisconsin, 53095, United States

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Brasschaat, 2930, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Liège, 4000, Belgium

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Turnhout, 2300, Belgium

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Barretos, 14784-400, Brazil

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Londrina, 86010-640, Brazil

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Porto Alegre, 91350-200, Brazil

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Recife, 50670-420, Brazil

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Salvador, 40170-070, Brazil

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São Paulo, 04039-001, Brazil

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Antofagasta, 1240000, Chile

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Santiago, 8380455, Chile

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Santiago, Chile

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Bogotá, Colombia

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Cali, Colombia

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Brno, 656 53, Czechia

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České Budějovice, 370 87, Czechia

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Pardubice, 520 03, Czechia

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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Prague, 180 00, Czechia

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Tábor, 390 03, Czechia

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V Uvalu 84, 150 06, Czechia

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Nyíregyháza, 4400, Hungary

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Székesfehérvár, 8000, Hungary

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Szombathely, 9700, Hungary

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Ansārinagar, 110 029, India

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Bhopal, 462001, India

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Hyderabad, 500082, India

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Jaipur, 302013, India

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Kolkata, 700054, India

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Manipal, 576 104, India

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Marg Jaipur, 302004, India

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Mumbai, 400012, India

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Pune, 411001, India

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Trivandrum, 2417, India

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Vellore, 632004, India

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Aviano, 33081, Italy

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Bergamo, 24128, Italy

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Carpi, 41012, Italy

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Genova, 16132, Italy

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Prato, 59100, Italy

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Reggio Emilia, 42100, Italy

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Varese, 21100, Italy

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Floriana, VLT 14, Malta

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Mexico City, 06720, Mexico

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México, 01090, Mexico

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México, 14140, Mexico

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Bialystok, 15-027, Poland

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Lodz, 90-553, Poland

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Poznan, 61-878, Poland

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Ivanovo, 153040, Russia

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Kazan, Tatarstan, 420029, Russia

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Kazan, Tatarstan, 420111, Russia

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Krasnodar, 350040, Russia

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Lipetsk, 398005, Russia

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Moscow, 107005, Russia

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Moscow, 115478, Russia

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Moscow, 121356, Russia

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Moscow, 59401, Russia

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Nizhny Novgorod, 603081, Russia

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Obninsk, 249020, Russia

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Ryazan, 390046, Russia

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Saint Petersburg, 191014, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, 197758, Russia

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Yaroslavl, 150054, Russia

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Bardejov, 08501, Slovakia

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Bratislava, 812 50, Slovakia

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Nitra, 949 01, Slovakia

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Trnava, 917 75, Slovakia

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A Coruña, 15006, Spain

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Madrid, 28040, Spain

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Málaga, 29010, Spain

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Oviedo, 33011, Spain

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Salamanca, 37007, Spain

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Seville, 41013, Spain

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Cherkasy, 18009, Ukraine

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Dnipro, 49102, Ukraine

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Donetsk, 83092, Ukraine

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Kyiv, 03022, Ukraine

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Lviv, 79031, Ukraine

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Sumy, 40022, Ukraine

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Ternopil, 46023, Ukraine

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Uzhhorod, 88000, Ukraine

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Caracas, 1010, Venezuela

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Caracas, 1053, Venezuela

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Caracas, 1060, Venezuela

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Related Publications (1)

• Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

  PMID: 29522361 DERIVED

Related Links

• CSP-D6997C00002.PDF
• D6997C00002 Study Report Synopsis

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Faslodex Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2004
• First Posted: December 14, 2004
• Study Start: February 13, 2005
• Primary Completion: February 27, 2009
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026
• Results First Posted: June 15, 2010

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

PL (3); ES (6); CO (2); BE (8); HU (3); US (14); IN (11); IT (7); RU (16); CL (3); VE (3); ME (3); BR (6); UA (8); SL (4); MA (1); CZ (8)