Lumpectomy Without Radiation for Breast Cancer

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

671 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Lumpectomy Without Radiation for Breast Cancer?

The research indicates that breast-conserving surgery, which includes lumpectomy followed by radiation, is as effective as mastectomy for early-stage breast cancer in terms of survival and local control. However, the effectiveness of lumpectomy without radiation is not directly addressed, suggesting that radiation is typically recommended to minimize the risk of cancer returning. ^{1 2 3 4 5}

Is lumpectomy without radiation generally safe for breast cancer patients?

Research indicates that lumpectomy and other breast-conserving surgeries are generally safe for most women with early-stage breast cancer, similar to mastectomy, but there is limited information on long-term safety without radiation. ^{6 7 8 9 10}

How is the treatment of lumpectomy without radiation for breast cancer different from other treatments?

Lumpectomy without radiation is unique because it involves removing the breast tumor while avoiding the additional step of radiation therapy, which is typically used to kill any remaining cancer cells. This approach may be suitable for patients with small, low-grade tumors or older patients, offering a less intensive treatment option compared to the standard combination of surgery and radiation. ^{11 12 13 14 15}

What is the purpose of this trial?

This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.

Research Team

Julia Wong, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Breast-conserving therapy of breast cancer]. [2016]

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

Decision Making in the Surgical Management of Invasive Breast Cancer-Part 1: Lumpectomy, Mastectomy, and Contralateral Prophylactic Mastectomy. [2018]

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

Primary radiation therapy as an alternative to mastectomy for early-stage breast cancer. [2006]

4. Australia pubmed.ncbi.nlm.nih.gov

Benchmarking clinical practice quality: an audit of ipsilateral breast tumor recurrence in patients managed for T1/T2 breast carcinoma. [2018]

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

Mastectomy from the perspective of a medical oncologist. [2019]

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

Nipple Sparing Mastectomy as a Risk-Reducing Procedure for BRCA-Mutated Patients. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Breast conserving surgery after neoadjuvant therapy for large primary breast cancer. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Reduction mammaplasty and mastopexy in previously irradiated breasts. [2016]

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

Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. [2022]

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

The need to improve informed consent for breast cancer patients. [2022]

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

Results of salvage mastectomy for local recurrence after breast-conserving surgery without radiation therapy. [2019]

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

Lumpectomy with and without radiation for early-stage breast cancer and DCIS. [2007]

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

Minimally invasive techniques in breast cancer treatment. [2019]

14. Japan pubmed.ncbi.nlm.nih.gov

A prospective analysis of two studies that used the 5-mm interval slices and 5-mm margin-free method for ipsilateral breast tumor recurrence after breast-conserving surgery without radiotherapy. [2023]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Innovations in locoregional treatments of breast cancer]. [2010]