Health TrialsbyHealthPanel

5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer

ConditionsBreast CancerInvasive Carcinoma of BreastDuctal Breast Carcinoma in Situ
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Utah

About this trial

The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participant aged ≥ 18 years.

Grade 3 invasive histology

Estrogen receptor positivity less than 5%

Lymphovascular invasion

Disqualifiers

Bilateral breast cancer.

Prior radiation therapy to the chest.

Prior chemotherapy.

Recurrent disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation Therapy

    Radiation

    Undergo hypofractionated radiation therapy

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: 5 fractions of radiotherapy (Arm 1)Experimental treatment 1 intervention
Group B: 9 fractions of radio therapy (Arm 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.

To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.

Time frame
3 years

Secondary outcomes

1

Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type

To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.

Time frame
5 years
2

Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by severity (as defined by the NIH CTCAE, version 5.0)

To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.

Time frame
5 years
3

Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness

To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.

Time frame
5 years
4

Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration

To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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