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New treatment option for Breast Cancer Invasive
Official title BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT04891068
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, being studied as a potential treatment for breast cancer invasive.
Also referred to as Vidaza.
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
- To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.
- 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
You may be able to join if
- Age ≥ 18 years of age at time of consent
- ECOG 0, 1, or 2
- Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or...
- Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as...
- HER2 positive (IHC or FISH)
You likely can't join if
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor...
- Any type of breast implants
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment...
See the full eligibility criteria
- Age ≥ 18 years of age at time of consent
- ECOG 0, 1, or 2
- Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3/N0-N1/M0 by physical exam or radiologic studies
- Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO/CAP guidelines) OR II. ER positive (as determined by...
- HER2 positive (IHC or FISH)
- Node positive
- Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)
- PR negative (IHC) OR III. HER 2 positive (as defined by ASCO/ACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration...
- Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and/or ipsilateral axillary lymph nodes or investigational agents) with...
- Any type of breast implants
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating medical...
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.
- Other major comorbidity, as determined by study PI
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.