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A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase 2 Trial Of 4 Months Preoperative Letrozole 2.5 mg Daily For Postmenopausal Women With Estrogen Receptor Positive And/Or Progesterone Receptor Positive T2, T3, T4a-c, N0-2, M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy


OBJECTIVES:

Primary

- Develop a predictive model of response (based on gene expression profiling) in
postmenopausal women with estrogen- and/or progesterone-receptor positive stage II,
IIIA, or IIIB breast cancer treated with neoadjuvant letrozole.

Secondary

- Determine the response rate in patients treated with this drug.

- Determine changes in Ki67 proliferation rates in patients treated with this drug.

- Determine the rate of improvement in surgical outcomes in patients treated with this
drug.

- Determine the long-term outcomes in patients treated with this drug.

- Determine the safety of this drug in these patients.

- Determine mechanisms of resistance to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of
disease progression. Patients then undergo breast surgery one day after the last dose of
letrozole. Patients with partial response after 16 weeks may continue to receive letrozole
for an additional 8 weeks before undergoing breast surgery.

Patients are followed within 4 weeks after definitive surgery and then annually for 10
years.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed infiltrating adenocarcinoma of the breast by core needle
biopsy

- Clinical stage T2-T4a-c, N0-2, M0

- Palpable and measurable disease

- Previously untreated disease

- Benefits from neoadjuvant therapy that would improve surgical outcome AND meets
criteria for 1 of the following:

- Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk
for positive margins or poor cosmetic outcome) AND patient desires
breast-conserving surgery

- Ineligible for lumpectomy due to size of primary tumor, but modified radical
mastectomy feasible AND patient desires breast-conserving surgery

- Inoperable disease AND systemic therapy required for disease to become operable
by modified radical mastectomy

- Bilateral primary tumors allowed provided both tumors are consistent with entry
criteria

- No inflammatory carcinoma (defined as peau d' orange affecting at least one third of
the breast)

- Direct extension of the tumor to the skin allowed

- No metastatic breast disease, except isolated ipsilateral supraclavicular
lymphadenopathy

- Hormone receptor status:

- Estrogen- and/or progesterone-receptor positive disease based on 10% or more
nuclear staining of the invasive component of the tumor

PATIENT CHARACTERISTICS:

Age

- Postmenopausal

Sex

- Female

Menopausal status

- Postmenopausal, defined as meeting 1 of the following criteria:

- Cessation of menstrual periods for at least 1 year

- Bilateral surgical oophorectomy

- Follicle-stimulating hormone and estradiol levels in the postmenopausal range

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No severe liver dysfunction that would preclude study participation

Renal

- Not specified

Other

- Willing and able to provide biopsy material

- Willing to undergo breast surgery after neoadjuvant treatment

- No condition (e.g., confusion, infirmity, or alcoholism) that would preclude study
compliance

- No other concurrent active and progressive invasive malignancies

- No other concurrent severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy or biological response modifiers for breast cancer

Chemotherapy

- No prior chemotherapy for breast cancer

- No concurrent chemotherapy for breast cancer

Endocrine therapy

- At least 2 weeks since prior hormone replacement therapy or phytoestrogenic herbal,
alternative, or over-the-counter (OTC) sex hormone remedies

- No prior hormonal agents for breast cancer

- No prior aromatase inhibitors, tamoxifen, raloxifene, or other antiestrogen or
selective estrogen receptor modulators

- No concurrent drugs known to affect sex hormone status, including hormone replacement
therapy or phytoestrogenic herbal, alternative, or OTC remedies

- No other concurrent endocrine therapy for breast cancer

Radiotherapy

- No prior radiotherapy for breast cancer

- No concurrent radiotherapy for breast cancer

Surgery

- Prior sentinel node biopsy allowed

- No other concurrent surgery for breast cancer

Other

- More than 30 days since prior non-approved or experimental drugs

- Concurrent bisphosphonates for osteoporosis allowed

- No other concurrent treatment for breast cancer

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Predictive model for response as assessed by gene expression profiling

Safety Issue:

No

Principal Investigator

Matthew J. Ellis, MD, PhD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000361963

NCT ID:

NCT00084396

Start Date:

October 2003

Completion Date:

March 2017

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110