Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
185 (estimated)
Sponsor
Medical College of Wisconsin · Other
Who this trial is looking for
This trial is looking for women with hormone receptor-positive breast cancer who need treatment before surgery. Participants will receive standard anti-estrogen treatment for 4 to 12 weeks.
Are You a Good Fit for This Trial?
Must not be takingStrong CYP2D6 inhibitors
You may be able to join if
I am a woman aged 18 or older.
I have been diagnosed with invasive breast cancer, stages I or II.
I have a tumor that is hormone receptor positive.
I have not received any treatment for my current breast cancer in the past two years.
I have had a breast mammogram and ultrasound within the last 60 days.
I am not pregnant or breastfeeding.
I have lymph nodes that are clinically negative.
I can provide informed consent to participate.
You may not be able to join if
I have advanced breast cancer (T4, N1-3 or M1).
I have another type of cancer besides non-melanomatous skin cancer or carcinoma in situ of the cervix.
I have purely non-invasive breast cancer.
I am male.
I have a medical or psychiatric condition that prevents me from participating.
I have had treatment for any malignancy in the last two years.
I am currently pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion 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 ex…
Inclusion 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.
Exclusion Criteria:
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
Medical College of Wisconsin Cancer Center Clinical Trials Office
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