Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00330317

Collaborator

(none)

300

Enrollment

Locations

Arm

57.5

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: letrozole	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neoadjuvant Hormone Therapy for Postmenopausal Women With HR+ Primary Breast Cancer: A Multi-center Study to Determine the Optimum Length of Treatment With Letrozole on Tumour Regression to Permit Breast Conserving Surgery.

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Nov 16, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole	Drug: letrozole 2.5mg letrozole once-daily Other Names: Femara, FEM345

Arm

Intervention/Treatment

Experimental: Letrozole

Drug: letrozole

2.5mg letrozole once-daily

Other Names:

Femara, FEM345

Outcome Measures

Primary Outcome Measures

Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound [12 months]

Secondary Outcome Measures

Reduction in tumour volume every 2 months throughout the study [12 months]
Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria [12 months]
Long term (5-year) local recurrence rate [5 years]
Safety and tolerability of the treatment prior to surgery [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
Clinical stage T2 or >T2 tumours which in the investigators' opinion would not be eligible for breast-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
Postmenopausal status defined by one of the following:

Women with an intact uterus AND
≥ 55 years of age, OR
< 55 years of age without menses for the last 5 years, OR
< 55 years of age and have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone.
Women without an intact uterus AND
≥ 55 years of age, OR
< 55 years of age and postmenopausal levels of follicle-stimulating hormone
Both ovaries removed (prior to the diagnosis of breast cancer).

Tumour measurable by clinical examination, mammography and ultrasound
Adequate bone marrow function as shown by:

WBC ≥ 3.5 x 10^9/L
ANC ≥ 1.5 x 10^9/L
Platelets ≥ LLN
Hb > 10 g/dL

Exclusion Criteria:

Multifocal disease (cancer that starts in several different sites)
Patients with bilateral breast tumours.
Patients who are eligible for breast conserving surgery.
Evidence of inflammatory breast cancer or distant metastasis.
Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.

The following additional treatments are NOT allowed during the treatment phase of the study:

Any other anti-cancer therapy
Hormone replacement therapy.
Estrogen cream (including any intra-vaginal preparation).
Steroids other than creams or inhalers.
Megestrol acetate for the treatment of hot flushes.
Radiation therapy.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Bournemouth	United Kingdom
2	Novartis Investigative Site	Brighton	United Kingdom
3	Novartis Investigative Site	Bristol	United Kingdom
4	Novartis Investigative Site	Crewe	United Kingdom
5	Novartis Investigative Site	Dundee	United Kingdom
6	Novartis Investigative Site	East Sussex	United Kingdom
7	Novartis Investigative Site	Epping	United Kingdom
8	Novartis Investigative Site	Farnworth	United Kingdom
9	Novartis Investigative Site	Gateshead	United Kingdom
10	Novartis Investigative Site	Glasgow	United Kingdom
11	Novartis Investigative Site	Hants	United Kingdom
12	Novartis Investigative Site	Leicester	United Kingdom
13	Novartis Investigative Site	Liverpool	United Kingdom
14	Novartis Investigative Site	London	United Kingdom
15	Novartis Investigative Site	Luton	United Kingdom
16	Novartis Investigative Site	Manchester	United Kingdom
17	Novartis Investigative Site	Newcastle	United Kingdom
18	Novartis Investigative Site	Poole	United Kingdom
19	Novartis Investigative Site	St. Leonards on Sea	United Kingdom
20	Novartis Investigative Site	West Smithfield	United Kingdom