Radiation Therapy for Early Stage Breast Cancer

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Chemotherapy, Immunotherapy, Experimental medications

Disqualifiers: Other malignancy, Collagen vascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects and side effects of radiation therapy to evaluate its effectiveness in treating women with early-stage breast cancer. It explores two methods of delivering radiation after surgery to target any remaining cancer cells. Women who have undergone a lumpectomy or mastectomy for breast cancer that hasn’t spread to distant parts of the body might be suitable candidates. Participants will receive either whole breast irradiation followed by an external beam boost, or the reverse order. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial allows you to continue taking tamoxifen, anastrozole, or other hormonal therapies. However, you cannot have chemotherapy during the trial and must wait at least 21 days after finishing radiation therapy to start or resume it. Other concurrent chemotherapy, immunotherapy, or experimental medications are not allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radiation therapy, like the treatments in this trial, is generally safe for early-stage breast cancer. External beam boost treatments, such as 3DCRT and IMRT, have demonstrated promising results. Studies have found that these methods are well-tolerated, with outcomes similar to traditional treatments over five years. When side effects occur, they are usually mild.

Whole breast irradiation is another method under study. A review of multiple studies has confirmed its safety and effectiveness. Patients report fewer breast symptoms with this treatment compared to others. Overall, current evidence suggests that both treatment types used in this trial are well-tolerated and safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for early-stage breast cancer because they explore different sequences of radiation therapy that might offer improved outcomes. Unlike the traditional approach of whole breast irradiation followed by a boost to the lumpectomy bed, one method in this trial flips the order, applying a 3DCRT/IMRT boost first. Another approach accelerates the whole breast irradiation, potentially shortening treatment time while maintaining effectiveness. These variations aim to enhance the precision of radiation delivery and minimize treatment duration, which could lead to better patient experiences and outcomes.

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

This trial compares two radiation therapy approaches for early-stage breast cancer. One arm uses an external beam boost, a focused method to increase the radiation dose to the tumor area. Studies have shown that this method achieves results similar to other well-known methods, with good long-term success in reducing cancer recurrence. The other arm involves whole breast irradiation, which treats the entire breast. Research indicates that whole breast irradiation effectively lowers the risk of cancer recurrence, with evidence supporting its safety and effectiveness. Both treatments in this trial aim to destroy any remaining cancer cells after surgery, increasing the chances of a successful outcome. ^{2 3 4 6 7}

Who Is on the Research Team?

Bruce G. Haffty

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for women with early stage breast cancer who've had a lumpectomy or mastectomy, without prior treatment for the opposite breast. They should have no distant spread of cancer, be pre- or post-menopausal with good performance status, and not pregnant. Those on hormone therapy may join but can't have other cancers in the last 5 years (except nonmelanoma skin cancer) and must use contraception if fertile.

Inclusion Criteria

I am currently on hormonal therapy like tamoxifen or anastrozole.

I am not currently on any chemotherapy, immunotherapy, or experimental drugs.

Fertile patients must use effective contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo either intracavitary balloon brachytherapy boost and AWBI or 3D-CRT/IMRT boost and AWBI for post-lumpectomy, or accelerated chest wall irradiation for post-mastectomy.

2-3 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at weeks 1, 4, and 8, then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Long-term

Multiple follow-up visits over several years

What Are the Treatments Tested in This Trial?

Interventions

• External Beam Boost
• Whole Breast Irradiation

Trial Overview

The study tests how well different methods of radiation therapy work after surgery to remove breast tumors. It aims to determine the effectiveness of whole breast irradiation with an external beam boost in killing any remaining tumor cells.

How Is the Trial Designed?

Group I: B Active Control 2 Interventions

Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost

Group II: A Active Control 2 Interventions

3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Rutgers Cancer Institute of New Jersey

Collaborator

Trials

72

Recruited

22,200+

Published Research Related to This Trial

In a study of 520 early-stage breast cancer patients, external-beam accelerated partial-breast irradiation (APBI) showed a low 10-year cumulative incidence of ipsilateral breast tumor recurrence (IBTR) at 3.7%, which is comparable to the 2.5% seen with whole-breast irradiation (WBI).

APBI resulted in significantly less acute and late toxicity, along with better cosmetic outcomes, indicating it may be a safer and more patient-friendly option compared to traditional WBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. Meattini, I., Marrazzo, L., Saieva, C., et al.[2021]

In a study of 167 patients receiving breast cancer treatment, the simultaneous integrated boost (SIB) method did not show a significant difference in the occurrence of moist desquamation compared to the sequential boost (SeB) method, indicating similar safety profiles for both approaches.

However, patients in the SeB arm experienced significantly more grade 2/3 dermatitis (38% vs 29%) and higher rates of pruritus (61% vs 43%), suggesting that SIB may lead to fewer side effects in terms of skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial. Paelinck, L., Gulyban, A., Lakosi, F., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3365530/

INITIAL EFFICACY RESULTS OF RTOG 0319: THREE ...

This prospective study (Radiation Therapy Oncology Group 0319) examines the use of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9332060/

Early Outcome, Cosmetic Result and Tolerability of an ...

IOERT versus external beam electrons for boost radiotherapy in stage I/II breast cancer: 10-year results of a phase III randomized study.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301613030812

Five-Year Outcomes, Cosmesis, and Toxicity With 3- ...

APBI delivered by 3D-CRT to the tumor bed for a selected group of early-stage breast cancer patients produces 5-year results similar to those achieved with ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01792726

A Comparison of Intra-operative Radiotherapy Boost With ...

An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After ...

5.

nature.com

nature.com/articles/s41598-024-73627-x

A systematic review on the techniques, long-term outcomes ...

The results of this NMA showed that external beam PBI with 3DCRT technique for early-stage breast cancer patients after breast-conserving ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11382807/

IMRT versus 3DCRT in Left-Sided Breast Cancer Patients with ...

The present study focused on 15 female breast cancer patients, for whom two treatment plans were devised per patient for the sake of comparison.

7.

redjournal.org

redjournal.org/article/S0360-3016(23)00523-0/fulltext

5-Year Results of the IMRT-MC2 Phase III Trial

Together with our 5-year results, these data underline the safety of the SIB application in adjuvant radiation therapy of patients with breast ...