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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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

Inclusion Criteria


Inclusion criteria:

1. 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)

2. Patients after menopause

3. Tumor measurable by clinical examination, mammography and ultrasound

4. Adequate bone marrow, renal and hepatic function

5. A life expectancy of at least 6 months.

Exclusion criteria:

1. Prior treatment with aromatase inhibitors or antiestrogens.

2. 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).

3. Patients with tumors in both breasts, evidence of inflammatory breast cancer or
distant metastasis

4. Patients who are eligible for breast conserving surgery.

5. 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.

Other protocol defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Germany: German Institute of Medical Documentation and Information

Study ID:

CFEM345EDE01

NCT ID:

NCT00535418

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • neoadjuvant treatment
  • treatment duration
  • Primary hormone receptor positive
  • breast cancer in postmenopausal women
  • Breast Neoplasms

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