Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
Pre-operative Hormone Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer: An Uncontrolled Phase IIb/III Trial to Assess Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
1 other identifier
interventional
35
0 countries
N/A
Brief Summary
This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedSeptember 5, 2017
August 1, 2017
2.1 years
September 24, 2007
August 31, 2017
Conditions
Keywords
Study Arms (1)
Letrozole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Female Breast Cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive (Clinical Stage \*T2, T3, T4a,b,c, N0, M0)
- Patients after menopause
- Tumor measurable by clinical examination, mammography and ultrasound
- Adequate bone marrow, renal and hepatic function
- A life expectancy of at least 6 months.
You may not qualify if:
- Prior treatment with aromatase inhibitors or antiestrogens.
- Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated), Patients with unstable angina, uncontrolled cardiac disease (e.g. Class II or IV New York Heart Association's Functional Classification).
- Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis
- Patients who are eligible for breast conserving surgery.
- Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Krainick-Strobel UE, Lichtenegger W, Wallwiener D, Tulusan AH, Janicke F, Bastert G, Kiesel L, Wackwitz B, Paepke S. Neoadjuvant letrozole in postmenopausal estrogen and/or progesterone receptor positive breast cancer: a phase IIb/III trial to investigate optimal duration of preoperative endocrine therapy. BMC Cancer. 2008 Feb 26;8:62. doi: 10.1186/1471-2407-8-62.
PMID: 18302747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
June 1, 2000
Primary Completion
July 1, 2002
Last Updated
September 5, 2017
Record last verified: 2017-08