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New treatment option for Breast Cancer
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
ClinicalTrials.gov ID: NCT06361940
What this study is testing
What is Aromatase inhibitors or tamoxifen?
Aromatase inhibitors or tamoxifen is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Unilateral diagnostic breast mammogram and ultrasound within 60 days of enrollment.
- Pathologically proven diagnosis of invasive breast cancer, clinical stage I or II.
- Patients must be clinically lymph node negative. Lymph node negativity must be confirmed by clinical exam and/or ultrasound imaging.
- The patient must be female.
- Age ≥18 years.
You likely can't join if
- American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
- Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
- Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- Men with breast cancer. Male breast cancer is a rare event and it is unclear if neoadjuvant endocrine treatment approach is safe in men.
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- Pregnant or lactating women are ineligible.
See the full eligibility criteria
- Unilateral diagnostic breast mammogram and ultrasound within 60 days of enrollment.
- Pathologically proven diagnosis of invasive breast cancer, clinical stage I or II.
- Patients must be clinically lymph node negative. Lymph node negativity must be confirmed by clinical exam and/or ultrasound imaging.
- The patient must be female.
- Age ≥18 years.
- 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...
- Human epidermal growth factor receptor 2 (HER2) /neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Bilateral breast cancer and/or multifocal, multicentric disease is allowed.
- 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...
- The patient must qualify for endocrine treatment (treatment of choice), per the treating medical oncologist.
- The patient must provide study-specific informed consent prior to study entry.
- 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.
- 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...
- 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...
- Strong cytochrome P450 2D6 (CYP2D6) inhibitors will be prohibited with tamoxifen, as it can decrease the how well it works of tamoxifen. There are no known strong interactions with aromatase inhibitors.
- American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
- Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
- Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
- Men with breast cancer. Male breast cancer is a rare event and it is unclear if neoadjuvant endocrine treatment approach is safe in men.
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
- Pregnant or lactating women are ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.