Radiation Therapy for Early-Stage Breast Cancer

Recruiting at 513 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NSABP Foundation Inc

Must be taking: Anti-HER2 therapy

Must not be taking: Sex hormones

Disqualifiers: Metastatic disease, T4 tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6.5 weeks

1636 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using sex hormonal therapy, such as birth control pills or ovarian hormone replacement therapy, before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Radiation Therapy for Early-Stage Breast Cancer?

Whole breast irradiation (WBI) is a standard treatment for early-stage breast cancer and has been shown to be effective in controlling the disease and maintaining breast appearance. Studies have also explored accelerated versions of WBI, which offer similar outcomes with shorter treatment times, making it more convenient for patients. ^{1 2 3 4 5}

Is radiation therapy for early-stage breast cancer safe?

Research shows that radiation therapy, including whole breast irradiation (WBI), is generally safe for early-stage breast cancer, with studies comparing different methods and reporting on patient experiences and side effects. Some studies focus on skin reactions and cosmetic outcomes, indicating that while there may be some side effects, they are typically manageable. ^{1 4 6 7 8}

How does whole-breast irradiation (WBI) differ from other treatments for early-stage breast cancer?

Whole-breast irradiation (WBI) is a treatment for early-stage breast cancer that involves delivering radiation to the entire breast over 5-6 weeks, which is different from newer approaches like hypofractionated WBI and accelerated partial-breast irradiation (APBI) that offer shorter treatment durations and target smaller areas, potentially increasing convenience and reducing costs. ^{3 9 10 11 12}

What is the purpose of this trial?

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Research Team

Norman Wolmark, MD

Principal Investigator

NSABP Foundation Inc

Eligibility Criteria

This trial is for early-stage breast cancer patients who've had surgery after chemotherapy. They must have T1-3, N1 cancer with confirmed axillary nodal involvement and no metastatic disease. Eligible participants should not be pregnant, have prior breast radiation, or severe systemic diseases. Performance status should be good (ECOG 0 or 1), and hormone receptor testing on the tumor is required.

Inclusion Criteria

My breast cancer was tested for HER2 before starting chemotherapy.

I am fully active or restricted in physically strenuous activity but can do light work.

My breast cancer was tested for estrogen and progesterone receptors following ASCO/CAP guidelines.

Exclusion Criteria

You have mental health or addiction issues that could make it hard for you to participate in the study.

My breast cancer is advanced (T4) or inflammatory.

I have an active collagen vascular disease like dermatomyositis, lupus, or scleroderma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiation therapy. Lumpectomy patients receive whole breast radiation therapy for 5 weeks followed by a boost for 1.5 weeks. Mastectomy patients receive regional nodal and chestwall radiation therapy for 5 weeks.

6.5 weeks

Systemic Therapy

All patients receive systemic therapy as planned, including hormonal therapy for hormone-receptor positive breast cancer and trastuzumab or other HER2 therapy for HER2-positive breast cancer.

Follow-up

Participants are monitored for safety and effectiveness after treatment at 6, 12, 18, and 24 months, and then yearly for 8 years.

10 years

Treatment Details

Interventions

• Chestwall XRT
• Regional Nodal XRT
• WBI

Trial Overview The study compares standard radiation therapy to comprehensive radiation therapy in treating early-stage breast cancer post-surgery. It aims to determine which method is more effective at killing remaining tumor cells without extensive side effects.

Participant Groups

Group I: Group 2B Mastectomy: Regional nodal XRT and chestwall XRT Experimental Treatment 2 Interventions

Mastectomy patients undergo regional nodal radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks.

Group II: Group 2A lumpectomy: Regional nodal XRT with WBI Experimental Treatment 2 Interventions

Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

Group III: Group 1A Lumpectomy: no regional nodal XRT with WBI Active Control 1 Intervention

Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.

Group IV: Group 1B Mastectomy: No regional nodal or chestwall XRT Active Control 1 Intervention

Mastectomy patients do not undergo radiation therapy.

Who Is Running the Clinical Trial?

NSABP Foundation Inc

Lead Sponsor

Trials

89

Recruited

140,000+

Radiation Therapy Oncology Group

Collaborator

Trials

191

Recruited

64,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Partial breast irradiation (PBI) is linked to a higher risk of local recurrence in early-stage breast cancer compared to whole breast irradiation (WBI), with an odds ratio of 1.69, indicating a significant concern for patients considering PBI.

Despite the increased local recurrence risk, PBI is associated with lower odds of death without breast cancer recurrence (OR 0.55), suggesting a potential survival benefit, particularly for women with smaller hormone receptor-positive tumors and no nodal involvement when treated with external beam radiation therapy (EBRT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity and clinical outcomes of partial breast irradiation compared to whole breast irradiation for early-stage breast cancer: a systematic review and meta-analysis. Korzets, Y., Fyles, A., Shepshelovich, D., et al.[2019]

In a study of 131 early-stage breast cancer patients, both accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) showed similar patient-reported outcomes in terms of quality of life, pain, and fatigue after treatment, indicating both methods are effective.

Patients receiving APBI reported less skin color change and breast elevation compared to those undergoing WBI, suggesting that APBI may have a cosmetic advantage in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience. Jethwa, KR., Kahila, MM., Mara, KC., et al.[2022]

Both accelerated partial-breast irradiation (APBI) techniques using 3D conformal radiation therapy (3DCRT) showed significantly improved conformity compared to conventional whole-breast irradiation (WBI) in a study involving 15 patients.

The APBI techniques maintained good dose homogeneity and did not significantly increase radiation exposure to surrounding organs at risk, indicating they are safe and effective alternatives for post-lumpectomy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric evaluation of 3Dconformal acceleratedpartial-breast irradiation vs. whole-breast irradiation: A comparative study. Kumar, R., Sharma, SC., Kapoor, R., et al.[2021]

Accelerated partial breast irradiation (APBI) offers a shorter treatment option compared to traditional whole breast irradiation (WBI), potentially increasing access to breast-conserving therapy for women with early-stage breast cancer.

While APBI techniques show similar local control rates to WBI in selected patients, the follow-up data on their long-term efficacy is limited, necessitating careful patient selection based on evidence-based criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: potential roles following breast-conserving surgery. Biagioli, MC., Harris, EE.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Toxicity and clinical outcomes of partial breast irradiation compared to whole breast irradiation for early-stage breast cancer: a systematic review and meta-analysis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Five-year outcomes, cosmesis, and toxicity with 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Shortened radiation therapy schedules for early-stage breast cancer: a review of hypofractionated whole-breast irradiation and accelerated partial breast irradiation. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Accelerated whole breast irradiation with intensity-modulated radiotherapy to the prone breast. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Physician- and Patient-Reported Outcomes of the MC1635 Phase 3 Trial of Ultrahypofractionated Versus Moderately Hypofractionated Adjuvant Radiation Therapy After Breast-Conserving Surgery. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Phase II Trial of Once Weekly Hypofractionated Breast Irradiation for Early Stage Breast Cancer. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of Toxicity and Cosmetic Outcomes After Accelerated Partial Breast Irradiation or Whole Breast Irradiation Using 3-Dimensional Conformal External Beam Radiation Therapy. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Dosimetric evaluation of 3Dconformal acceleratedpartial-breast irradiation vs. whole-breast irradiation: A comparative study. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: A New Standard of Care? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: potential roles following breast-conserving surgery. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013. [2022]