Lumpectomy Without Radiation for Breast Cancer

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: Endocrine therapy

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Multicentric disease, T4 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

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether patients with early-stage breast cancer can skip radiation therapy after a lumpectomy, which removes the tumor while preserving the breast. The researchers aim to determine if radiation is necessary for all patients or if some can safely avoid it. Suitable participants are those who have had a lumpectomy for a breast tumor 2 cm or smaller, with specific hormone receptor characteristics, and who are open to taking hormone therapy afterward. This study targets individuals whose cancer hasn't spread to the lymph nodes and who haven't received previous systemic treatments for breast cancer. As a Phase 2 trial, the 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 does not specify if you need to stop taking your current medications. However, you cannot have had any prior systemic therapy for breast cancer, like chemotherapy or hormonal therapy, and these cannot be part of your future treatment plan.

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

Research has shown that breast-conserving surgery, such as a lumpectomy, is generally safe for patients with early-stage breast cancer. Large studies have found that this surgery, when combined with radiation, is as safe as more invasive surgeries like a mastectomy, which removes the whole breast.

This trial explores the possibility of skipping radiation, but breast-conserving surgery itself has a strong safety record. Evidence suggests that keeping the nipple during surgery is safe for many early-stage cancers.

In simple terms, this type of surgery has been well-tolerated by patients, with many studies supporting its safety and effectiveness for treating breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the possibility of skipping radiation therapy for some breast cancer patients. Typically, breast cancer treatment after a lumpectomy includes radiation therapy to reduce the risk of cancer returning. However, this trial looks at cases where radiation might be unnecessary, especially for patients with a low-risk score confirmed by Prosigna. If successful, it could mean fewer side effects and a less burdensome treatment journey for those eligible, as they would only need adjuvant endocrine therapy instead of both radiation and endocrine treatments.

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

Research has shown that breast-conserving surgery, or lumpectomy, is a safe and effective treatment for early-stage breast cancer. Studies have found that long-term survival rates for lumpectomy are similar to those for mastectomy, which involves removing the entire breast. Additionally, the chance of cancer returning within five years is low for women who choose this surgery. This trial will evaluate outcomes for participants eligible for omission of radiotherapy (RT) based on a low-risk score confirmed by Prosigna. Participants in this group will receive adjuvant endocrine therapy. Those ineligible for omission of RT, due to intermediate- or high-risk scores, may still receive RT. Breast-conserving surgery remains a dependable option for many patients. However, some evidence suggests a slightly higher risk of cancer recurrence in the same area compared to mastectomy. Overall, for many women with early-stage breast cancer, breast-conserving surgery can be as effective as a mastectomy. ^{1 6 7 8 9}

Who Is on the Research Team?

Julia Wong, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women aged 50-75 with early-stage, favorable-risk breast cancer who've had a lumpectomy. They must be node-negative, have a life expectancy over 5 years, and can commit to endocrine therapy. Exclusions include prior systemic breast cancer treatment, other recent cancers (except certain skin/cervical), or significant comorbidities.

Inclusion Criteria

Your doctor believes you will live for more than 5 years.

I am willing to undergo hormone therapy after my main cancer treatment.

My breast cancer was removed with clear margins.

Exclusion Criteria

I haven't had any cancer diagnosis in the past 5 years, except for non-melanoma skin cancer or cervical lesions.

Current addictive or psychiatric disorder which may preclude protocol adherence

I have not received any systemic therapy for breast cancer before joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast-conserving surgery (lumpectomy) and are assessed for eligibility to omit radiotherapy based on Prosigna test results. Eligible participants receive adjuvant endocrine therapy.

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up physical examinations and mammography to evaluate the 5-year risk of local regional recurrence.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Breast-Conserving Surgery
• Prosigna

Trial Overview The PRECISION Trial is testing if patients with specific types of early breast cancer can safely skip radiation after surgery. It uses the Prosigna test to identify those at low risk of recurrence who might not need further radiation treatment.

How Is the Trial Designed?

Group I: Ineligible for omission of RT Active Control 1 Intervention

Prosigna confirms intermediate- or high-risk score. Participants with intermediate- or high-risk scores will be ineligible for omission of radiotherapy (RT). Some patients with low-risk scores may elect to receive RT.

Group II: Eligible for omission of RT Active Control 1 Intervention

Prosigna confirms low risk score. Participant will be eligible for omission of therapy and chooses to do so. Patient will receive adjuvant endocrine therapy.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

NanoString Technologies, Inc.

Industry Sponsor

Trials

11

Recruited

2,100+

Published Research Related to This Trial

Breast conserving surgery is safe for patients with breast tumors that have been effectively downstaged after neoadjuvant therapy, showing a similar recurrence rate (7.9%) to those with early breast cancer who underwent primary surgery (7.8%).

The study involved 88 patients in the neoadjuvant therapy group and 191 patients in the early breast cancer group, with a mean follow-up of over 61 months, indicating that age was the most significant predictor of recurrence in the neoadjuvant group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast conserving surgery after neoadjuvant therapy for large primary breast cancer. Tiezzi, DG., Andrade, JM., Marana, HRC., et al.[2021]

Breast conservation surgery followed by radiation therapy is as effective as mastectomy for early-stage breast cancer, providing comparable local control and survival rates, based on various studies.

With proper patient selection and surgical techniques, 80-90% of patients achieve good to excellent cosmetic outcomes, which may encourage more women to seek early detection of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary radiation therapy as an alternative to mastectomy for early-stage breast cancer. Ratanatharathorn, V., Powers, WE.[2006]

In a study of 18 patients who underwent reduction mammaplasties and mastopexies on previously irradiated breasts, 94% achieved successful outcomes with their preoperative goals, indicating that these surgeries can be effective even after breast conservation therapy.

While there were some minor complications (22% of patients), only one major complication occurred (6%), suggesting that with careful consideration, elective breast surgeries can be performed safely in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction mammaplasty and mastopexy in previously irradiated breasts. Spear, SL., Rao, SS., Patel, KM., et al.[2016]

In a clinical audit of 1252 patients treated with adjuvant radiation for early-stage breast cancer, the ipsilateral breast tumor recurrence rate was only 0.56%, indicating effective treatment outcomes that align with international standards.

The study reported low rates of late toxicity, with only 6.8% of patients experiencing grade 1 toxicity and 1.6% experiencing grade 2-3 toxicity, suggesting that adjuvant radiotherapy is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmarking clinical practice quality: an audit of ipsilateral breast tumor recurrence in patients managed for T1/T2 breast carcinoma. Suttie, C., Back, M., Donovan, J., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524818/

Comparative Effectiveness Analysis of Lumpectomy and ... In data analysis, our main finding is that lumpectomy and mastectomy have comparable long-term overall survival for early-stage elderly female breast cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815734/

Secondary Resections and Survival After Breast ... These data suggest that mastectomy may be more effective in preventing recurrence compared with BCS. However, despite the increased local ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225001200

Comparing the oncologic outcomes of breast-conserving ... Breast conservation surgery after neoadjuvant chemotherapy shows higher positive margins. •. Five-year overall survival rates are similar for BCS with or ...

4. mayoclinic.org mayoclinic.org/medical-professionals/cancer/news/breast-conserving-surgery-is-a-safe-and-effective-treatment-option-for-women-with-multiple-ipsilateral-breast-cancer/mac-20554388

Breast-conserving surgery is a safe and effective treatment ... Research from Mayo Clinic finds breast-conserving surgery yields a low five-year recurrence rate for women with multiple ipsilateral breast ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa022152

Twenty-Year Follow-up of a Randomized Trial Comparing ... After 20 years of follow-up, we found no significant difference in overall survival among women who underwent mastectomy and those who underwent lumpectomy with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4115749/

20-year results of EORTC 10801 Large multicenter clinical trials have demonstrated the safety of breast conserving surgery and radiation (BCT) compared to modified radical mastectomy ...

7. academic-med-surg.scholasticahq.com academic-med-surg.scholasticahq.com/article/141854-total-lumpectomy-vs-nipple-sparing-lumpectomy-long-term-outcomes-and-quality-of-life-considerations-in-breast-cancer-surgery-a-narrative-review

Total Lumpectomy vs Nipple-Sparing Lumpectomy The evidence to date indicates that sparing the nipple during breast-conserving surgery is oncologically safe for most early cancers, with no ...

8. nature.com nature.com/articles/s41598-025-16215-x

Survival comparison of breast conserving therapy and ... Cohort studies have suggested that breast-conserving therapy (BCT) offers better survival outcomes compared to mastectomy in patients with ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833981

Long-Term Oncologic Outcome of Breast-Conserving ... Many previous studies have demonstrated that BCT is not inferior to mastectomy and yields superior cosmetic outcomes.