Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.

NCT07394946 | Not Yet Recruiting Phase 2

• 1 other identifier: CCH-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery. The main questions this study aims to answer are: Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes? Can treatment with letrozole reduce the need for extensive lymph node surgery? How safe and tolerable is long-term letrozole treatment? This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group. Participants will: Take letrozole 2.5 mg by mouth once daily for one year Attend regular clinic visits for physical exams, blood tests, and imaging studies Undergo surgery after completing treatment Be followed for up to two years to monitor cancer recurrence and survival

Conditions

Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer

Keywords

Early-Stage Breast Cancer; HER2-Negative Breast Cancer; Node-Positive Breast Cancer; Hormone Receptor-Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Extent of Axillary Nodal Pathologic Complete Response (pCR)

  Proportion of postmenopausal, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer patients achieving pathological complete response (pCR) in axillary lymph nodes after one year of neoadjuvant letrozole therapy, assessed by sentinel lymph node biopsy (SLNBx).

  From baseline (pre-treatment) to the end of one-year letrozole treatment

Secondary Outcomes (3)

• Loco-Regional Relapse Rate

  Assessed at 6, 12, and 24 months post-treatment initiation

• Distant Relapse Rate

  Assessed at 6, 12, and 24 months post-treatment initiation

• Safety and Tolerability

  Monitored continuously during the 1-year treatment period, reported at 3-month intervals.

Study Arms (1)

Letrozole

EXPERIMENTAL

Letrozole, Oral, 2.5mg daily, for 1 year

Drug: Letrozole

Interventions

Letrozole DRUG

Letrozole is an oral aromatase inhibitor administered at a dose of 2.5 mg once daily for one year. It is used as neoadjuvant therapy in postmenopausal women with early-stage, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer to reduce tumor size and axillary lymph node involvement before surgery.

Also known as: Letrozole, Oral, 2.5mg daily, for 1 year

Letrozole

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Patients aged 18 to 69 years.
• Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria.
• Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade.
• Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography.
• Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy.
• Hormone Receptor Status: Patients must be estrogen receptor (ER) positive and progesterone receptor (PR) positive/negative, with HER2 status negative.

You may not qualify if:

• Age: Patients aged under 18 or over 69 years.
• Tumor Size: Patients with a primary tumor larger than T2 \>5cm or with N2 disease.
• Histological Type: Infiltrating lobular carcinoma or other non-invasive breast cancer types.
• Prior Treatments: Previous treatment with neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NACT).
• Comorbidities: Significant comorbidities that preclude administration of anesthesia or compromise patient safety.
• Disease Characteristics: Patients with multicentric or multifocal disease, as defined by imaging or histopathological findings.

Sponsors & Collaborators

• Cancer Care Hospital & Research Centre Foundation, Lahore: lead

Study Sites (1)

Cancer Care Hospital and Research Centre Foundation

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr. Eram Akram

CONTACT

+923365163135; umemustafa@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Both participants and investigators are aware that the participants are receiving letrozole. No placebo or comparator group is involved. Open-label design allows for safety monitoring and practical administration in a neoadjuvant cancer setting.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same intervention - letrozole 2.5 mg orally daily for one year - and outcomes will be measured within this single group. There is no randomization, control, or comparator group, making it a single-arm study.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)