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RecruitingPhase 3

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for women age 65 or older with early-stage breast cancer that uses estrogen to grow (ER+). It compares 3 months of hormone-blocking medicine before surgery with going straight to surgery. Surveys will check how well patients tolerate the medicine and take it as directed.

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. Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 65 or older.
  • Have invasive breast cancer that is ER+ and HER2-negative, with no signs of cancer in nearby lymph nodes. The cancer may or may not use progesterone to grow (PR+ or PR-).
  • Can care for yourself and are up and about for more than half of your waking hours (ECOG score 0–2).
  • Can have and have chosen surgery that removes the cancer but keeps the breast.
  • Can receive radiation treatment and hormone-blocking medicine, such as tamoxifen or an aromatase inhibitor.
  • Can take pills and are willing to take hormone-blocking medicine for 3 months before surgery.
  • Agree to follow the study’s lifestyle rules and all study steps, and be available for the full study.
  • Sign and date a form agreeing to join the study.

Who can't join

  • Have cancer in both breasts at the same time.
  • Have cancer in separate areas of the same breast.
  • Have taken tamoxifen or an aromatase inhibitor before.
  • Have had radiation treatment to the breast that now has cancer.
  • Have another cancer that is growing or needs treatment with cell-killing chemotherapy or radiation. Some stable, low-risk cancers may be allowed after review by the study doctors.
  • Take or plan to take a medicine that strongly blocks a liver enzyme called CYP2D6, such as fluvoxamine or paroxetine, and cannot use a hormone-blocking medicine that works without this enzyme.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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 judgment may be allowed after discussion with multi-site PI. * 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.

Study sites (6)

CT

VA