Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

NCT00880009 | Terminated Phase 2 Results

• 3 other identifiers: 3160A6-2207B18710102008-006252-21
• Study Type: interventional
• Target: 16
• Locations: 7 countries
• Sites: 11

Brief Summary

This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) Based on Independent Radiologist

  Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported.

  Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Secondary Outcomes (9)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Part 1 Baseline up to 28 days after the last dose

• Progression-Free Survival (PFS) Based on Investigator

  Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

• Percentage of Participants With Objective Response

  Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

• Overall Survival (OS)

  Part 2 Baseline until death or up to 36 months

• Duration of Response (DR)

  Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Study Arms (2)

1

EXPERIMENTAL

Combination of Bosutinib and Letrozole

Drug: Bosutinib; Drug: Letrozole

2

ACTIVE COMPARATOR

Letrozole

Drug: Letrozole

Interventions

Bosutinib DRUG

400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

1

Letrozole DRUG

2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

1

Eligibility Criteria

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

You may qualify if:

• Surgically sterile or post-menopausal women.
• Confirmed pathologic diagnosis of breast cancer.
• Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.
• Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.
• At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.
• Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
• More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.
• Adjuvant endocrine therapy \<=12 months prior to day 1 of treatment.
• Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
• Bone or skin as the only site of disease.
• Extensive visceral disease or active Central Nervous System (CNS) disease.
• Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
• Major surgery or radiotherapy within 14 days of treatment day.
• Inadequate hepatic/renal/bone marrow function.
• History of clinically significant or uncontrolled cardiac disease.
• Serious concurrent illness.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

American Institute of Research

Whittier, California, 90603, United States

Location

Joliet Oncology Hematology Associates

Joliet, Illinois, 60435, United States

Location

Oncology Specialists SC

Niles, Illinois, 60714, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 84202, United States

Location

AZ Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Cancer Hospital, Academy of Med Science and Peking Union Med

Beijing, Beijing Municipality, 100021, China

Location

UNIMED Medical Institute

Hong Kong, Hong Kong

Location

Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

Budapest, 1122, Hungary

Location

Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdr

Warsaw, 04125, Poland

Location

Johns Hopkins Singapore International Medical Centre

Singapore, 308433, Singapore

Location

Related Publications (1)

• Moy B, Neven P, Lebrun F, Bellet M, Xu B, Sarosiek T, Chow L, Goss P, Zacharchuk C, Leip E, Turnbull K, Bardy-Bouxin N, Duvillie L, Lang I. Bosutinib in combination with the aromatase inhibitor letrozole: a phase II trial in postmenopausal women evaluating first-line endocrine therapy in locally advanced or metastatic hormone receptor-positive/HER2-negative breast cancer. Oncologist. 2014 Apr;19(4):348-9. doi: 10.1634/theoncologist.2014-0021. Epub 2014 Mar 27.

  PMID: 24674874 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bosutinib; Letrozole

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

Limitations and Caveats

Results are not provided because the study was terminated prior to part 2 due to unfavorable risk benefit ratio of the study treatment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 13, 2009
• Study Start: July 30, 2009
• Primary Completion: May 31, 2010
• Study Completion: May 31, 2010
• Last Updated: September 27, 2021
• Results First Posted: November 5, 2012

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); CN (1); HK (1); US (5); HU (1); PL (1); SG (1)