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

ConditionBreast Cancer Female
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age65+
SponsorUniversity of Virginia

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Bilateral synchronous breast cancer

Multicentric disease

Prior use of Tamoxifen or aromatase inhibitors

History of ipsilateral breast radiation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tamoxifen, Letrozole, Anastrozole, or Exemestane

    Drug

    Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.

Treatment groups

354 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants who omit Radiation Therapy (RT) and are non-adherent to Endocrine Therapy (ET)

Proportion of participants who omit RT and are non-adherent to ET as measure through the 24-month adjuvant follow-up visit

Time frame
24 months
2

Proportion of participants who are treated with Breast Cancer Surgery (BCS) + RT + AET

Proportion of participants who are treated with BCS + RT + AET as measured through the 24-month adjuvant follow-up visit

Time frame
24 months

Secondary outcomes

1

Treatment with pre-ET and its impact on Decision Conflict

Using Patient Reported Outcomes (PRO) assessments of Decisional Conflict Scale (DCS) to determine whether treatment with pre-ET lessens Decision Conflict. The DCS is a validated measure of patient perceptions of uncertainty surrounding treatment choices. The minimum score is a 0, which is interpreted as no decisional conflict, and the maximum score is 64, which is interpreted as the highest decisional conflict.

Time frame
24 months
2

Treatment with pre-ET and its impact on Decision Regret

Using Patient Reported Outcomes (PRO) assessments of Decision Regret Scale (DRS) to determine whether treatment with pre-ET lessens Decision Regret. The DRS is a validated, 5-item scale that measures self-reported regret after health care decisions. DRS scores range from 0 (no regret) to 100 (high regret).

Time frame
24 months
3

Assessing whether patient's final treatment correlates with their beliefs about breast cancer

Using the PRO assessment "Beliefs about Illness Questionnaire (BIP-Q)" to determine patient's beliefs about breast cancer. The BIP-Q is a validated survey to assess cognitive and emotional perceptions of illness.

Time frame
7 months
4

Assessing whether patient's final treatment correlates with their beliefs about breast cancer

Using the PRO assessment "Beliefs about Medicine Questionnaire (BMQ)" to determine patient's beliefs about breast cancer. The BMQ is a validated survey designed to capture patients' perceptions about medicines and medicine adherence.

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov
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