Overview

Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer

Status:
Recruiting
Trial end date:
2024-11-30
Target enrollment:
0
Participant gender:
Female
Summary
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers. After undergoing a core needle biopsy for tissue acquisition, study participants will take a 7- to 56-day (1-8 weeks) course of letrozole in accordance with standard of care. They will then undergo definitive surgical resection of their primary tumor (mastectomy vs lumpectomy) as per standard of care guidelines.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
Cancer Prevention Research Institute of Texas
Treatments:
Hormones
Letrozole
Criteria
Inclusion Criteria:

1. Eligibility waivers are not permitted. Subjects must meet all of the inclusion and
exclusion criteria to be registered to the study. Study treatment may not begin until
a subject is registered.

2. Patients must provide informed written consent

3. ECOG performance status 0-2.

4. Clinical stage operable I, II or III invasive mammary carcinoma, which is ER-positive
by IHC and HER2-negative by Herceptest (0 or 1+) or not amplified by FISH as per
routine clinical testing Patients who have measurable residual tumor at the primary
site Patients who will undergo surgical treatment with either segmental resection or
total mastectomy

5. Measurable tumor i. Measurable disease: a mass that can be reproducibly measured by
physical exam and calipers or ultrasound and is at least 1 cm in size

6. Post-menopausal female subjects ≥18 years of age, as defined by any of the following:

- Subjects at least 55 years of age;

- Subjects under 55 years of age and amenorrhoeic for at least 12 months or
follicle-stimulating hormone (FSH) values ≥40 IU/L and estradiol levels ≤40 pg/mL
(140 pmol/L) or in postmenopausal ranges per local or institutional reference
ranges;

- Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at
least 6 months.

- (There is no upper age limit for enrollment to this study)

7. No prior chemotherapy for this primary breast cancer.

8. Patients with a prior history of contralateral breast cancer are eligible if they have
no evidence of recurrence of their initial primary breast cancer.

9. Women may have been taking tamoxifen or raloxifene as a preventive agent prior to
study entry but must have discontinued the drug for at least 21 days prior to study
enrollment.

10. Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens
tablets, USP, [Premarin]), at least 7 days prior to receiving the first dose of
randomized therapy.

11. Patients must have adequate hepatic and renal function. All tests must be obtained
less than 4 weeks from study entry. This includes:

1. Creatinine <2X upper limits of normal

2. Bilirubin, SGOT, SGPT <1.5X upper limits of normal

12. Able to swallow and retain oral medication

Exclusion Criteria:

1. Patients with locally advanced disease who are candidates for other preoperative
chemotherapy at the time of initial evaluation. This may include patients with locally
advanced disease such as:

- Inflammatory breast cancer (T4d)

- Fixed axillary lymph node metastases (N2)

- Metastasis to ipsilateral internal mammary node (N3)

2. Locally recurrent breast cancer

3. Evidence of distant metastatic disease (i.e. lung, liver, bone, brain, etc.)

4. Serious medical illness that in the judgment of the treating physician places the
patient at high risk of operative mortality.

5. Severe uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea,
severe malnutrition, short gut syndrome)

6. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.

7. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of letrozole.