Accelerated Radiation Therapy for Breast Cancer

(PRART Trial)

Recruiting in New York (>99 mi)

+2 other locations

Overseen By Sharanya Chandrasekhar

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Previous radiation, Male breast cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Accelerated Radiation Therapy for Breast Cancer?

Research shows that accelerated partial breast irradiation (APBI), a component of the treatment, can be as effective as whole-breast irradiation for early-stage breast cancer, with studies indicating comparable local control and potential for increased survival in resource-constrained settings. ^{1 2 3 4 5}

Is accelerated radiation therapy for breast cancer safe for humans?

Research shows that accelerated radiation therapy, including methods like accelerated partial breast irradiation (APBI) and three-dimensional conformal radiotherapy (3D-CRT), is generally safe for humans, with studies focusing on both acute (short-term) and late (long-term) side effects. These treatments have been evaluated for early-stage breast cancer and have shown manageable levels of normal tissue toxicity. ^{1 3 6 7 8}

How is accelerated radiation therapy for breast cancer different from other treatments?

Accelerated radiation therapy for breast cancer is unique because it shortens the treatment time to just three weeks, compared to the traditional six-week course. This approach, known as accelerated partial breast irradiation (APBI), targets only the area around the lumpectomy site, potentially reducing side effects and making it more convenient for patients. ^{1 5 9 10 11}

What is the purpose of this trial?

Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).

Research Team

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for women who've had a specific breast surgery for early-stage cancer (Stage 0, T1-T2) with no cancer left at the edges of removed tissue and no spread to lymph nodes. It's not open to men, those treated within 60 days after chemotherapy or 90 days post-surgery if they received chemo, or anyone previously radiated on the same breast.

Inclusion Criteria

I have had a segment of my breast surgically removed.

My breast cancer was removed with clear margins.

My breast cancer is contained and hasn't spread beyond its original site.

Exclusion Criteria

It has been over 60 days since my last chemotherapy session.

It's been over 90 days since my last surgery, or I've had chemotherapy after surgery.

I am a male diagnosed with breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1) or 10 fractions (Arm 2)

2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Radiation therapy - 2 weeks
• Radiation therapy - 3 weeks

Trial Overview The study compares two schedules of radiation therapy after breast surgery: one group receives standard treatment over three weeks while another gets an experimental shorter course over two weeks. Both groups also get extra radiation focused on where the tumor was.

Participant Groups

Group I: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions Experimental Treatment 1 Intervention

Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.

Group II: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions Experimental Treatment 1 Intervention

Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions

Radiation therapy - 3 weeks is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Radiation therapy for:

• Breast cancer
• Ductal carcinoma in situ (DCIS)
• Early-stage breast cancer

Approved in United States as Radiation therapy for:

• Breast cancer
• Ductal carcinoma in situ (DCIS)
• Early-stage breast cancer
• Locally advanced breast cancer

Approved in Canada as Radiation therapy for:

• Breast cancer
• Ductal carcinoma in situ (DCIS)
• Early-stage breast cancer

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 141 patients with early-stage breast cancer, 3D conformal radiotherapy (3D-CRT) for accelerated partial breast irradiation (APBI) showed a very low 5-year recurrence rate of only 0.9%, indicating strong local control of the disease.

The treatment also resulted in excellent cosmetic outcomes, with 95% of patients reporting good to excellent results after more than 5 years of follow-up, suggesting that 3D-CRT APBI is both effective and preserves breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Horst, KC., Fasola, C., Ikeda, D., 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]

Adopting hypofractionated whole breast irradiation and accelerated partial breast irradiation (APBI) can lead to improved survival rates and a higher likelihood of remaining disease-free for women undergoing breast cancer treatment, with a 4% increase in survival and a 7% increase in disease-free status at 15 years compared to conventional schedules.

In women who had lumpectomies, the hypofractionation model showed a 62% chance of remaining alive with an intact breast, compared to 54% in the conventional model, highlighting the potential benefits of shorter radiation schedules in improving patient outcomes in emerging economies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nation-Scale Adoption of Shorter Breast Radiation Therapy Schedules Can Increase Survival in Resource Constrained Economies: Results From a Markov Chain Analysis. Khan, AJ., Rafique, R., Zafar, W., et al.[2018]

Accelerated partial breast irradiation (APBI) is an advanced form of hypofractionated external beam radiation therapy (HERT) that allows for faster treatment due to targeting a smaller area, which may improve patient convenience and comfort.

Both APBI and HERT are currently being tested in randomized trials, highlighting their potential as effective treatment options for breast cancer, although they are still considered investigational.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an advanced form of hypofractionation. Budrukkar, A.[2019]

Accelerated partial breast irradiation (APBI) is a promising new radiotherapy method for breast cancer patients, showing local control rates comparable to traditional whole breast radiotherapy in recent studies.

Ongoing phase III trials are investigating the safety and efficacy of various APBI techniques to determine if they can effectively replace whole breast radiotherapy for women opting for breast conservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: where do we stand? Dirbas, FM.[2019]

In a study of 473 patients with early-stage breast cancer, once-per-day accelerated partial breast irradiation (APBI) showed excellent locoregional control with a 3-year recurrence-free survival rate of 99.2%, similar to accelerated hypofractionated whole breast irradiation (AWBI).

APBI resulted in significantly fewer acute and late toxicities compared to AWBI, with no grade 3 toxicities observed, making it a safer alternative for patients who meet the ASTRO-APBI guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen. Lee, HI., Kim, K., Kim, JH., et al.[2022]

Accelerated partial breast irradiation using three-dimensional conformal external-beam radiation (APBI-3DCRT) is feasible for early-stage breast cancer in Chinese female patients, with a total dosage of 34 Gy delivered safely after breast-conserving surgery.

The study found that while patients experienced mild acute toxicity, such as breast edema and skin erythema, there were no significant acute injuries to the heart or lungs, indicating a favorable safety profile for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acute toxicity of 3-dimensional conformal external-beam accelerated partial-breast irradiation for early-stage breast cancer after breast-conserving surgery in Chinese female patients. Li, FY., He, ZY., Xue, M., et al.[2022]

In a study of 44 patients with low-risk stage I-II breast cancer, accelerated partial breast irradiation (APBI) using 3D conformal radiotherapy showed a very low local recurrence rate of 2.3% over 5 years, with a disease-free survival rate of 96.3%.

The treatment had a favorable safety profile, with mostly mild side effects (grade 1) and excellent cosmetic outcomes, as rated by both patients (86% good/excellent) and physicians (84% good/excellent).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. Mózsa, E., Mészáros, N., Major, T., et al.[2021]

Accelerated partial breast irradiation (APBI) shows significantly better uniformity and conformity in radiation delivery compared to external beam radiation therapy (EBRT), suggesting it may be more effective in targeting the tumor bed while sparing surrounding healthy tissue.

The study, which analyzed dosimetric parameters in 24 patients with left-sided breast cancer, indicates that APBI could minimize side effects and reduce treatment duration, making it a promising option for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Of Accelerated Partial Breast Radiation Therapy And External Beam Radiation Therapy By Treatment Planning Indices. Hejazi, P., Tirtash, MJ., Khoshnazar, AK.[2022]

In a study of 61 early-stage breast cancer patients, three-dimensional conformal radiation therapy (3D-CRT) for accelerated partial-breast irradiation (APBI) effectively covered the planning target volume (PTV) with minimal dose to surrounding healthy tissues, achieving over 93% coverage at the prescribed dose.

The treatment resulted in low mean doses to the ipsilateral lung (1.8 Gy) and heart (0.8 Gy), indicating that 3D-CRT APBI is a safe and noninvasive option that could broaden access to effective breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. Taghian, AG., Kozak, KR., Doppke, KP., et al.[2007]

Accelerated Partial Breast Irradiation (APBI) offers a promising alternative to conventional six-week radiotherapy, allowing women with early-stage breast cancer to complete treatment in just five days, which may increase access to breast conservation options.

Successful outcomes with APBI depend heavily on careful patient selection and quality assurance in brachytherapy, highlighting the importance of these factors in ensuring effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Arthur, DW., Vicini, FA., Kuske, RR., et al.[2015]

References

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

Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. [2018]

2. 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]

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

Nation-Scale Adoption of Shorter Breast Radiation Therapy Schedules Can Increase Survival in Resource Constrained Economies: Results From a Markov Chain Analysis. [2018]

4. India pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an advanced form of hypofractionation. [2019]

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

Accelerated partial breast irradiation: where do we stand? [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Feasibility and acute toxicity of 3-dimensional conformal external-beam accelerated partial-breast irradiation for early-stage breast cancer after breast-conserving surgery in Chinese female patients. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation with external beam three-dimensional conformal radiotherapy. Five-year results of a prospective phase II clinical study. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison Of Accelerated Partial Breast Radiation Therapy And External Beam Radiation Therapy By Treatment Planning Indices. [2022]

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

Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. [2007]

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

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]