Clinical trial · Interventional
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
NCT00696072CI-TRIAL-00022560completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A1
- interventionNames
- Drug: Dasatinib
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- A2
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
- timeFrame
- First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
- description
- CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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
References
Publications (0)
Data not yet available
No reference posted for this study.