TEAM II A randomised, multicentre, prospective, phase III trial investigating TEAM IIa: Neoadjuvant hormonal therapy with exemestane for three versus six months. and / or TEAM IIb: The efficacy and safety of the addition of ibandronate to adjuvant hormonal therapy in postmenopausal women with hormone receptor positive early breast cancer.
Recruiting
- Conditions
- Breast Cancer, Neoadjuvant hormonal therapy, Aromatase inhibitor, Adjuvant therapy, Bisphosphonates
- Registration Number
- NL-OMON27856
- Lead Sponsor
- TEAM II Study Group
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2478
Inclusion Criteria
TEAM IIa:
1. Female patients with histologically, by core needle biopsy-proven, invasive adenocarcinoma of the breast.
Exclusion Criteria
TEAM IIa:
1. M1 disease by clinical examination according to the NABON guideline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TEAM IIa: <br /><br>Objective response rate (immediately prior to surgery) of the primary breast tumour, assessed by palpation, which is preferably performed by the same person.<br /><br /><br>TEAM IIb: <br /><br>Three years disease free survival.
- Secondary Outcome Measures
Name Time Method