Radiation Therapy for Early Stage Breast Cancer

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

200 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Radiation Therapy for Early Stage Breast Cancer, involving External Beam Boost and Whole Breast Irradiation?

Research shows that using a boost (extra dose of radiation) along with whole-breast irradiation can improve local cancer control rates, meaning it helps prevent the cancer from coming back in the treated area. Studies also suggest that combining these treatments can reduce the number of visits needed while maintaining effectiveness and potentially reducing side effects. ^{1 2 3 4 5}

Is radiation therapy for early-stage breast cancer safe for humans?

Radiation therapy for early-stage breast cancer, including whole breast irradiation with a boost, is generally safe but can cause side effects like skin irritation (dermatitis) and breast hardness. These side effects are usually manageable, but they can sometimes lead to discomfort or treatment interruptions. ^{2 3 5 6 7}

How is the radiation therapy treatment for early-stage breast cancer different from other treatments?

This treatment uses a unique approach by incorporating a concomitant boost (additional radiation dose given at the same time) during whole-breast irradiation, which may reduce treatment time compared to the traditional method of giving a boost after whole-breast irradiation. ^{2 4 5 7 8}

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Research Team

Bruce G. Haffty

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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.

I have not had cancer in my other breast or at the same time in the same breast.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Dosimetric comparison of simultaneous integrated boost with whole-breast irradiation for early breast cancer. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of whole breast irradiation with a concomitant boost: analysis of 121 cases treated at the Institute of Cancerology of Lorraine]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Dose-escalated simultaneous integrated boost radiotherapy in early breast cancer (IMPORT HIGH): a multicentre, phase 3, non-inferiority, open-label, randomised controlled trial. [2023]

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

Early-stage breast cancer treated with 3-week accelerated whole-breast radiation therapy and concomitant boost. [2018]

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

Reduction in radiation-induced morbidity by use of an intercurrent boost in the management of early-stage breast cancer. [2010]

6. Ireland pubmed.ncbi.nlm.nih.gov

Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial. [2018]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Results of intraoperative radiotherapy given as a boost after breast conserving-surgery. [2022]

8. United States 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. [2021]