Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Irada Ibrahim-zada

Status and phase: Active, not recruiting; Phase 2

Conditions: Breast Cancer; Node-negative Breast Cancer; Breast Carcinoma; HER2-negative Breast Cancer

Treatments: Drug: Letrozole 2.5mg; Drug: Anastrozole 1mg; Drug: Tamoxifen; Drug: Exemestane 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05150652

MCC-21-BRE-54

Details and patient eligibility

About

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed invasive breast cancer, clinically stage I-II.
• Clinically lymph node negative
• Eligible for anti-endocrine treatment (per medical oncologist)
• Postmenopausal women
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Progesterone receptor negativity
• High grade tumor
• Synchronous non-breast malignancy
• Receiving any other investigational agents that could impact the efficacy of this trial regimen
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Anastrozole, Letrozole, Exemestane, Tamoxifen or other agents used in study
• Uncontrolled intercurrent illness
• Medical, psychiatric or other condition and/or social situations that would limit compliance with study requirements

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Neoadjuvant Endocrine Therapy

Experimental group

Description:

Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.

Treatment:

Drug: Exemestane 25 mg

Drug: Tamoxifen

Drug: Letrozole 2.5mg

Drug: Anastrozole 1mg