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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.


Phase 3
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CFEM345EGB07

NCT ID:

NCT00330317

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Letrozole
  • Breast Conserving Surgery
  • NeoAdjuvant
  • Early Breast Cancer
  • Breast Neoplasms

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