Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Hormones

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Enzyme Inhibitors

Once enrolled, patients would be treated with the current standard-of-care endocrine therapy.

Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status.

Aromatase inhibitors or tamoxifen

Medical College of Wisconsin Cancer Center Clinical Trials Office

Lubna N Chaudhary, MD

This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).

Patients with HR+ HER2- node-negative breast cancers generally undergo surgical resection upfront, followed by adjuvant chemotherapy, if needed, in addition to adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to assess the tumor response to this treatment modality is lost and very difficult to assess. This study offers the unique opportunity to assess the responsiveness of breast tumors to endocrine therapy while the tumors are still in vivo by treating patients with endocrine therapy before surgery and assessing molecular changes with treatment. By comparing pre- and post-treatment levels of molecular markers with advanced omic analysis in individual tumors, the investigators expect to identify predictors of responsiveness to existing agents and identify new candidate therapeutic targets.

Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer

Pathologists will use immunohistochemistry (IHC) to determine the average count of tumor protein expression. IHC is reported categorically as 0,1, 2 or 3. Any increase between these categories is considered increase.

Pathologists will use immunohistochemistry to determine the average count of tumor protein expression. IHC is reported categorically as 0,1,2 or 3. Any increase between these categories is considered increase.

Medical College of Wisconsin

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer	NCT06361940	Breast Cancer	Aromatase inhib...	18 Years -	Medical College of Wisconsin
Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer	NCT06361940	Breast Cancer	Aromatase inhib...	18 Years -	Medical College of Wisconsin

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