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Ultrahypofractionated Whole Breast Radiation Following Chemotherapy

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-100
SponsorMetroHealth Medical Center

About this trial

This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)

Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed

Any receptor status is allowed (ER/PR/Her2-neu)

Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision

Disqualifiers

Patients with stage IV BC

Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)

Prior thoracic or breast RT

Brachytherapy or intraoperative RT (IORT)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ultra-hypofractionated radiation

    Radiation

    RT, delivered via external beam, 5.2 Gy per fraction for 5 fractions following BCS and neoadjuvant or adjuvant chemotherapy. Specific adjuvant/neoadjuvant therapies are at the discretion of the treating Medical Oncologist.

Treatment groups

213 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary(1)

Incidence of acute toxicities during and up to 3 months following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT

Time frame
up to 3 months
2

Primary (2)

Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT

Time frame
Up to 2 years

Secondary outcomes

1

Secondary (1)

Incidence of acute toxicities during and up to 3 months following completion of RT for BC patients who received neoadjuvant chemotherapy vs adjuvant chemotherapy

Time frame
Up to 3 months
2

Secondary (2)

Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who received neoadjuvant chemotherapy vs adjuvant chemotherapy

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

MetroHealth Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: