Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00696072
• Date of registration: 10/06/2008
• Primary sponsor: Bristol-Myers Squibb
• Public title: Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
• Scientific title: Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
• Date of first enrolment: October 2008
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00696072
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: For participation information at a USA site use a phone number below. For site information outside the USA please email:

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable
locally recurrent or metastatic disease

- Has measurable or evaluable-only disease

- Is female, =18 yrs of age, post menopausal or surgically sterile

- HER2 negative, HR+, ER+ and/or PgR+ breast cancer

- 0-1 prior chemotherapy regimen for metastatic disease.

- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior

- Prior tamoxifen therapy is allowed

- No AI therapy for >1 year without recurrence

Exclusion Criteria:

- Pregnant or breast feeding

- Prior hormonal therapy for metastatic or locally recurrent disease

- >1 chemotherapy regimen for metastatic disease

- Pleural or pericardial effusion

- Serious cardiac condition



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Dasatinib + Letrozole

Drug: Letrozole

Primary Outcome(s)

Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib [Time Frame: (CBR equal to CR+PR+SD =6 months)]

Secondary Outcome(s)

Bone Mineral Density changes [Time Frame: between baseline and 6 months]

Changes in bone markers [Time Frame: at 6 months and 1 year]

Effect on bone pain [Time Frame: at each clinic visit]

Median PFS in patients in both Arms [Time Frame: at 6 and 12 months]

Overall response rate & CBR in patients who crossover to either Arm 1b or Arm 2b [Time Frame: at 2 years]

Overall response rate in patients who receive letrozole plus dasatinib or single-agent letrozole [Time Frame: at 2 years]

PFS for both treatment arms [Time Frame: at 6- and 12-months]

Time to treatment failure (TTF) [Time Frame: at 6 months and 1 year]

Toxicity [Time Frame: at each clinic visit]

Secondary ID(s)

CA180-185

USOR 06-185

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

US Oncology Research