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PRISM Trial: Partial Breast Versus Whole Breast Radiation in Early Breast Cancer

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorJinnah Postgraduate Medical Centre

About this trial

Breast-conserving surgery followed by radiotherapy is a standard treatment for women with early-stage breast cancer. Whole breast irradiation (WBI) is the current standard approach, but partial breast irradiation (PBI), which treats only the area surrounding the original tumor, may reduce radiation exposure to healthy tissues while maintaining similar treatment effectiveness.

The PRISM Trial is a prospective, multicenter, phase II randomized controlled trial that will compare ultra-hypofractionated PBI and WBI using the same radiation schedule of 26 Gy delivered in five fractions with intensity-modulated radiotherapy (IMRT). One hundred eligible women with early-stage breast cancer will be randomly assigned to receive either PBI or WBI after breast-conserving surgery.

The primary objective is to compare acute treatment-related skin toxicity between the two treatment approaches using both clinician-reported Common Terminology Criteria for Adverse Events (CTCAE v6.0) and patient-reported outcomes (PRO-CTCAE). Secondary objectives include evaluation of early and late toxicity, dosimetric parameters, normal tissue complication probability (NTCP), and the relationship between radiation dose distribution and clinical toxicity over 12 months of follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged ≥45 years.

Newly diagnosed, histologically confirmed breast carcinoma, including Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), or Ductal Carcinoma in Situ (DCIS).

Early-stage disease (T1-T2, node-negative [N0]), with no evidence of distant metastasis.

Hormone receptor-positive disease (ER and/or PR positive).

Disqualifiers

Age <45 years.

Multicentric disease.

Locally advanced or node-positive disease (T3-T4 and/or N+) or evidence of distant metastasis.

Lobular Carcinoma In Situ (LCIS).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultra-Hypofractionated Partial Breast Irradiation

    Radiation

    Ultra-hypofractionated partial breast irradiation (PBI) delivered using intensity-modulated radiotherapy (IMRT). A total dose of 26 Gy in 5 once-daily fractions will be delivered over 5-7 days to the protocol-defined partial breast target volume following breast-conserving surgery.

  • Ultra-Hypofractionated Whole Breast Irradiation

    Radiation

    Ultra-hypofractionated whole breast irradiation (WBI) delivered using intensity-modulated radiotherapy (IMRT). A total dose of 26 Gy in 5 once-daily fractions will be delivered over 5-7 days to the whole breast following breast-conserving surgery.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Partial Breast Irradiation (PBI)Experimental treatment 1 intervention
Group B: Whole Breast Irradiation (WBI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Acute Treatment-Related Adverse Events by CTCAE Grade and Acute Treatment-Related Symptoms Reported Using PRO-CTCAE

Number of participants experiencing acute treatment-related adverse events, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, and number of participants reporting acute treatment-related symptoms using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE).

Time frame
3 months after completion of radiotherapy

Secondary outcomes

1

Number of Participants With Late Treatment-Related Adverse Events by CTCAE Grade and Late Treatment-Related Symptoms Reported Using PRO-CTCAE

Number of participants experiencing late treatment-related adverse events, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, and number of participants reporting late treatment-related symptoms using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE).

Time frame
6 months and 12 months after completion of radiotherapy
2

Dosimetric Parameters

Dose-volume histogram (DVH) parameters for the breast planning target volume (PTV), heart, and ipsilateral lung, including V95%, V105%, mean dose, and maximum dose for the breast PTV; mean dose, V5Gy, and V25Gy for the heart; and mean dose, V5Gy, and V20Gy for the ipsilateral lung.

Time frame
Baseline at the time of radiation treatment planning

Other outcomes

Sponsors and contacts

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

Jinnah Postgraduate Medical Centre

Lead sponsor

Source ClinicalTrials.gov

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