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New treatment option for Breast Cancer Female
Official title Pre-Operative Window of ET to Inform RT Decisions (POWER II)
ClinicalTrials.gov ID: NCT06507618
What this study is testing
What is Tamoxifen, Letrozole, Anastrozole, or Exemestane?
Tamoxifen, Letrozole, Anastrozole, or Exemestane is an investigational medicine, being studied as a potential treatment for breast cancer female.
Also referred to as Endocrine Therapy.
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 a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups: Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older, women only
You may be able to join if
- (summary):
- Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
- ECOG performance status 0-2
- Females, aged ≥ 65 years
- Patient is eligible for BCS and opted for BCS
You likely can't join if
- Bilateral synchronous breast cancer
- Multicentric disease
- Prior use of Tamoxifen or aromatase inhibitors
- History of ipsilateral breast radiation therapy
- Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies...
- Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does...
See the full eligibility criteria
- (summary):
- Diagnosis of ER+, PR +/-, and HER2- non amplified invasive breast cancer and clinically negative nodes
- ECOG performance status 0-2
- Females, aged ≥ 65 years
- Patient is eligible for BCS and opted for BCS
- Patient is a candidate for radiation therapy
- Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)
- Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS
- Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Bilateral synchronous breast cancer
- Multicentric disease
- Prior use of Tamoxifen or aromatase inhibitors
- History of ipsilateral breast radiation therapy
- Has a known additional malignancy that is progressing and/or requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's...
- Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Charlottesville, Virginia, United States
- Culpeper, Virginia, United States
- Fairfax, Virginia, United States
- Newport News, Virginia, United States
- Richmond, Virginia, 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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Charlottesville, Virginia, United States; Culpeper, Virginia, United States; Fairfax, Virginia, United States; Newport News, Virginia, United States; Richmond, Virginia, 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.