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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330317
• Other study ID #: CFEM345EGB07
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2006
• Last updated: February 3, 2017
• Start date: February 2006
• Est. completion date: November 16, 2010

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 16, 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive

2. 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.

3. 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).

4. Tumour measurable by clinical examination, mammography and ultrasound

5. 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:

1. Multifocal disease (cancer that starts in several different sites)

2. Patients with bilateral breast tumours.

3. Patients who are eligible for breast conserving surgery.

4. Evidence of inflammatory breast cancer or distant metastasis.

5. 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• letrozole
2.5mg letrozole once-daily

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Bournemouth
United Kingdom	Novartis Investigative Site	Brighton
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Crewe
United Kingdom	Novartis Investigative Site	Dundee
United Kingdom	Novartis Investigative Site	East Sussex
United Kingdom	Novartis Investigative Site	Epping
United Kingdom	Novartis Investigative Site	Farnworth
United Kingdom	Novartis Investigative Site	Gateshead
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Hants
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Luton
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Newcastle
United Kingdom	Novartis Investigative Site	Poole
United Kingdom	Novartis Investigative Site	St. Leonards on Sea
United Kingdom	Novartis Investigative Site	West Smithfield

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Carpenter R, Doughty JC, Cordiner C, Moss N, Gandhi A, Wilson C, Andrews C, Ellis G, Gui G, Skene AI. Optimum duration of neoadjuvant letrozole to permit breast conserving surgery. Breast Cancer Res Treat. 2014 Apr;144(3):569-76. doi: 10.1007/s10549-014-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound		12 months
Secondary	Reduction in tumour volume every 2 months throughout the study		12 months
Secondary	Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria		12 months
Secondary	Long term (5-year) local recurrence rate		5 years
Secondary	Safety and tolerability of the treatment prior to surgery		5 years

External Links

•   Results for CFEM345EGB07 from the Novartis Clinical Trials website