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

NCT00880009

Last updated date
Study Location
Pfizer Investigational Site
Whittier, California, 90603, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
Official Title  ICMJE A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Letrozole Versus Letrozole Alone As First Line Therapy In Post-Menopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
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.
Detailed Description This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Bosutinib
    400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
  • Drug: Letrozole
    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
Study Arms  ICMJE
  • Experimental: 1
    Combination of Bosutinib and Letrozole
    Interventions:
    • Drug: Bosutinib
    • Drug: Letrozole
  • Active Comparator: 2
    Letrozole
    Intervention: Drug: Letrozole
Publications * 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, Duvillié L, Láng 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)
16
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2009)
250
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   China,   Hong Kong,   Hungary,   Poland,   Singapore,   United States
Removed Location Countries Australia,   Brazil,   Malaysia
 
Administrative Information
NCT Number  ICMJE NCT00880009
Other Study ID Numbers  ICMJE 3160A6-2207
B1871010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP