RECRUITING

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

Conditions

Breast Cancer hormone receptor-positive HER2-negative endocrine therapy neoadjuvant anastrozole letrozole exemestane tamoxifen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients with Hormone Receptor-Positive HER2-negative Breast Cancer (MAPPER)

Quick Facts

Study Start:2024-09-30

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06361940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Unilateral diagnostic breast mammogram and ultrasound within 60 days of enrollment. 2. Pathologically proven diagnosis of invasive breast cancer, clinical stage I or II. 3. Patients must be clinically lymph node negative. Lymph node negativity must be confirmed by clinical exam and/or ultrasound imaging. 4. The patient must be female. 5. Age ≥18 years. 6. Estrogen and/or progesterone receptor positive tumor defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology/College of American Pathologists guidelines. 7. Human epidermal growth factor receptor 2 (HER2) /neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 9. Bilateral breast cancer and/or multifocal, multicentric disease is allowed. 10. Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history/physical examination, including breast exam (inspection and palpation of the breasts), clinically negative axillary lymph nodes, within 28 days prior to study entry. 11. The patient must qualify for endocrine treatment (treatment of choice), per the treating medical oncologist. 12. The patient must provide study-specific informed consent prior to study entry. 13. Patients with a prior history of breast cancer will be considered eligible, if they have completed all treatment (including endocrine therapy) more than two years prior to registration. 14. Patients must not have had a prior treatment for this breast cancer or for any malignancy diagnosed or treated within the past two years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix. 15. Women of childbearing age will be advised to use adequate methods of contraception. Adequate methods of contraception for premenopausal women include barrier methods and/or non-hormonal methods (Intrauterine devices etc.). 16. Strong cytochrome P450 2D6 (CYP2D6) inhibitors will be prohibited with tamoxifen, as it can decrease the efficacy of tamoxifen. There are no known strong interactions with aromatase inhibitors.	1. American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer. 2. Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix). 3. Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ). 4. Men with breast cancer. Male breast cancer is a rare event and it is unclear if neoadjuvant endocrine treatment approach is safe in men. 5. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent. 6. Pregnant or lactating women are ineligible.

Inclusion Criteria

Exclusion Criteria

1. Unilateral diagnostic breast mammogram and ultrasound within 60 days of enrollment.
2. Pathologically proven diagnosis of invasive breast cancer, clinical stage I or II.
3. Patients must be clinically lymph node negative. Lymph node negativity must be confirmed by clinical exam and/or ultrasound imaging.
4. The patient must be female.
5. Age ≥18 years.
6. Estrogen and/or progesterone receptor positive tumor defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology/College of American Pathologists guidelines.
7. Human epidermal growth factor receptor 2 (HER2) /neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
8. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
9. Bilateral breast cancer and/or multifocal, multicentric disease is allowed.
10. Appropriate pretreatment evaluations for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup: history/physical examination, including breast exam (inspection and palpation of the breasts), clinically negative axillary lymph nodes, within 28 days prior to study entry.
11. The patient must qualify for endocrine treatment (treatment of choice), per the treating medical oncologist.
12. The patient must provide study-specific informed consent prior to study entry.
13. Patients with a prior history of breast cancer will be considered eligible, if they have completed all treatment (including endocrine therapy) more than two years prior to registration.
14. Patients must not have had a prior treatment for this breast cancer or for any malignancy diagnosed or treated within the past two years, with the exception of non-melanomatous skin cancer, carcinoma in situ of the cervix.
15. Women of childbearing age will be advised to use adequate methods of contraception. Adequate methods of contraception for premenopausal women include barrier methods and/or non-hormonal methods (Intrauterine devices etc.).
16. Strong cytochrome P450 2D6 (CYP2D6) inhibitors will be prohibited with tamoxifen, as it can decrease the efficacy of tamoxifen. There are no known strong interactions with aromatase inhibitors.

1. American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
2. Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
3. Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
4. Men with breast cancer. Male breast cancer is a rare event and it is unclear if neoadjuvant endocrine treatment approach is safe in men.
5. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
6. Pregnant or lactating women are ineligible.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Lubna N Chaudhary, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Lubna N Chaudhary, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2029-12

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

hormone receptor-positive
HER2-negative
endocrine therapy
neoadjuvant
anastrozole
letrozole
exemestane
tamoxifen

Additional Relevant MeSH Terms

Breast Cancer