Radiation Therapy for Breast Cancer (DCIS Trial)

Recruiting in Palo Alto (17 mi)

+127 other locations

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Trans Tasman Radiation Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?Hypotheses: The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization. Overall Objectives: To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

Eligibility Criteria

This trial is for women over 18 with non-low risk DCIS of the breast, treated by breast conserving surgery. They must be clinically node-negative, able to start radiation within 12 weeks post-surgery, and have a life expectancy over 5 years. Exclusions include pregnant or lactating women, those with lymph node tumor cells, bilateral DCIS, previous contralateral breast cancer or serious diseases like scleroderma.

Inclusion Criteria

I am a woman aged 18 or older.

My breast cancer is non-invasive and confirmed by tissue analysis.

My cancer has not spread to my lymph nodes.

I can take care of myself and perform daily activities.

Exclusion Criteria

I have significant difficulty in performing daily activities.

I am not pregnant or breastfeeding.

I have cancer in both breasts at the same time.

My breast cancer has come back in the same area.

My cancer has spread to my lymph nodes.

I have DCIS in both breasts.

I have had cancer in my other breast before.

I have a serious illness like heart, lung, or kidney disease that prevents surgery or radiation.

Participant Groups

The study tests if adding a boost after whole breast radiation (WBRT) reduces recurrence in high-risk DCIS patients and compares shorter vs standard WBRT schedules. It also aims to find molecular signatures predicting invasive recurrence to personalize treatment.

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm 4 (Shorter WB fractionation + Boost)Experimental Treatment1 Intervention

Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)

Group II: Arm 2 (Shorter WB Fractionation)Experimental Treatment1 Intervention

Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)

Group III: Arm 1 (Standard WB Fractionation)Active Control1 Intervention

Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)

Group IV: Arm 3 (Standard WB fractionation+Boost)Active Control1 Intervention

Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)