Radiation Therapy for Early-Stage Breast Cancer

Not currently recruiting at 533 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if comprehensive radiation therapy is more effective than standard radiation therapy for individuals with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x-rays to kill cancer cells, and the study will compare different approaches, including Whole Breast Irradiation (WBI), to identify the most effective method. Participants will be divided into groups based on whether they have had a lumpectomy or a mastectomy, with each group receiving different types of radiation therapy. The trial seeks individuals who have had early-stage breast cancer, specific types of surgeries, and completed certain chemotherapy treatments. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options for early-stage breast cancer.

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 prior data suggests that this radiation therapy is safe for early-stage breast cancer patients?

Research has shown that radiation therapy, like the types studied in this trial, is usually well-tolerated. Previous studies found that regional nodal radiation therapy can slightly lower the risk of dying from breast cancer, depending on the patient's lymph node status. This indicates that the treatment can be helpful and generally safe.

For whole breast irradiation (WBI) with regional nodal radiation therapy, studies have compared it to other types of breast irradiation. The results suggest that while some side effects exist, they are often manageable. Patients receiving these treatments tend to have good long-term outcomes, with a lower chance of cancer recurrence.

Overall, past patients have handled these radiation therapies well, but like any treatment, side effects can occur. These might include skin irritation or tiredness, which are common with radiation therapy. It is important to discuss any concerns with the healthcare team conducting the trial. They can provide more personalized information based on individual health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy protocols for early-stage breast cancer because they explore different combinations of therapies to potentially improve patient outcomes. The trial is examining whole breast radiation (WBI) with or without regional nodal radiation, and in some cases, testing the efficacy of no radiation following mastectomy. By using advanced techniques like Intensity-Modulated Radiation Therapy (IMRT) or 3D Conformal Radiation Therapy (3D-CRT), these protocols aim to precisely target cancer cells while minimizing damage to surrounding healthy tissue. This could lead to fewer side effects and better overall quality of life for patients compared to traditional radiation methods.

What evidence suggests that this trial's radiation therapies could be effective for early-stage breast cancer?

Research has shown that regional nodal irradiation (RNI) can help reduce the risk of breast cancer recurrence. Specifically, adding RNI to whole-breast irradiation (WBI) lowers the chance of cancer returning, though it does not necessarily increase overall survival rates. In this trial, some participants will receive RNI with WBI, while others will receive WBI alone. Studies indicate that RNI can reduce the risk of dying from breast cancer by 1 to 5%, depending on lymph node involvement. Additionally, using chest wall radiation after a mastectomy and WBI after breast-conserving surgery is a well-established method for treating early-stage breast cancer. These findings suggest that comprehensive radiation, including RNI, may offer additional benefits in preventing cancer recurrence. ^{1 2 3 4 6}

Who Is on the Research Team?

Norman Wolmark, MD

Principal Investigator

NSABP Foundation Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955656/

Ultra-hypofractionated one-week locoregional radiotherapy ... Regional node irradiation (RNI) reduces breast cancer death risk by 1 to 5 %, varying with lymph node status [1]. Moderately hypofractionated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01872975

NCT01872975 | Standard or Comprehensive Radiation ... This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.TPS600

NRG Oncology/NSABP B-51/RTOG 1304: Phase III trial to ... This phase III post-NC trial evaluates if CWRNRT post-Mx or whole breast irradiation (WBI) with RNRT after BCS significantly reduces the IBCR-FI rate.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820919306652

Impact of Regional Nodal Irradiation and Hypofractionated ... Our study provides objective evidence that breast cosmetic outcome after XRT is strongly influenced by breast size at baseline and by surgical changes that ...

5. bioascend.com bioascend.com/wp-content/uploads/2022/08/2.-Torres-Mylin_Ultrashort-5-treatments_2022-DDHO_23JULY2022_TGS.pdf

ULTRA-SHORT RADIATION FOR EARLY-STAGE BREAST ... • 85% breast only XRT (no regional nodal XRT). • ~50% did not receive a boost ... • Data on 5 daily treatments to patients requiring regional nodal.

6. mdpi.com mdpi.com/1718-7729/30/8/545

Locoregional Treatment for Early-Stage Breast Cancer In this review, we will evaluate the current approach to the locoregional treatment of breast cancer including surgical, systemic therapy and radiation ...