Axillary Radiotherapy or Lymph Node Dissection for Breast Cancer

(OPBC-10/ NOAX Trial)

Not yet recruiting at 34 trial locations

Overseen By Walter P. Weber, Prof. Dr. med.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Stage IV, Contralateral cancer, Prior surgery, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatment approaches for individuals with breast cancer that has spread to the lymph nodes. It aims to determine if axillary radiotherapy (ART) improves arm-related quality of life and reduces the risk of lymphedema more effectively than the traditional surgery, axillary lymph node dissection (ALND). Participants must have node-positive breast cancer confirmed by tests and be prepared for surgery without any prior axillary surgery or regional radiotherapy. Those diagnosed with this type of breast cancer and eligible for surgery might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance treatment options for future patients.

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 team or your doctor.

What prior data suggests that these treatments are safe for breast cancer patients?

Research shows that axillary radiotherapy (ART) is generally safe for patients. Studies have found that ART can offer similar long-term results to traditional surgeries. For example, one study found that ART and lymph node surgery had similar outcomes over 10 years for breast cancer patients. This indicates that ART is well-tolerated and lacks major safety concerns.

In contrast, axillary lymph node dissection (ALND) carries some risks. Research indicates that the risk of lymphedema (swelling from lymph fluid build-up) is 65% lower with a less invasive procedure compared to ALND. However, ALND remains a standard treatment and has been used safely for many years, despite potentially having more side effects than ART.

In summary, both ART and ALND have been well-studied. While ALND might have more side effects like lymphedema, both are considered safe options for treating breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring axillary radiotherapy (ART) as an alternative to the current standard treatment of axillary lymph node dissection (ALND) for breast cancer. Unlike ALND, which requires surgical removal of lymph nodes, ART targets cancer cells using radiation, potentially sparing patients from surgery's physical side effects. ART may reduce complications like lymphedema and shoulder mobility issues, which are common with ALND. This approach could offer a less invasive option with similar effectiveness, providing a significant quality-of-life improvement for patients.

What evidence suggests that this trial's treatments could be effective for improving arm-related Quality of Life and reducing lymphedema in breast cancer patients?

This trial will compare axillary radiotherapy (ART) with axillary lymph node dissection (ALND) for managing breast cancer. Studies have shown that ART effectively reduces the chances of cancer recurrence in the breast area and provides excellent survival rates, making it a good alternative to surgery for controlling cancer spread. Participants in this trial may receive ART, which could help maintain a better quality of life by reducing complications. Conversely, some participants will receive ALND, a well-known method involving lymph node removal to prevent cancer spread. However, ALND carries a higher risk of causing lymphedema, which is swelling due to a buildup of lymph fluid, compared to ART. Evidence suggests that both ART and ALND offer similar survival outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Walter P. Weber, Prof. Dr. med.

Principal Investigator

Breast Surgery Service, University Hospital Basel

Are You a Good Fit for This Trial?

This trial is for patients with clinically node-positive breast cancer who are undergoing upfront surgery. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers for more information.

Inclusion Criteria

Written informed consent according to ICH/GCP regulations prior to any trial specific procedures

My cancer has spread to the lymph nodes, confirmed by tests but cannot be felt.

My most suspicious underarm lymph node has been marked with a clip.

Exclusion Criteria

No SLN identified in the axilla

Absence of clip in the specimen radiography

I have had radiation therapy to a specific area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo Tailored Axillary Surgery (TAS) including sentinel lymph node procedure and targeted excision of suspicious lymph nodes

1-2 weeks

Radiotherapy

Participants receive adjuvant breast irradiation and extended regional lymph node irradiation

6-8 weeks

Follow-up

Participants are monitored for arm-related Quality of Life (QoL) and occurrence of lymphedema

From baseline to 2 years after randomization

What Are the Treatments Tested in This Trial?

Interventions

• Axillary lymph node dissection (ALND)
• Axillary radiotherapy (ART)

Trial Overview The study is comparing two approaches after surgery: Axillary Radiotherapy (ART) and Axillary Lymph Node Dissection (ALND). It aims to determine which method is better for arm-related quality of life and reducing lymphedema within two years post-randomization.

How Is the Trial Designed?

Group I: Arm B (Investigational): ART Active Control 1 Intervention

1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).TAS + breast/chest wall and axillary irradiation (ART) 3. Radiotherapy: Axillary radiotherapy (ART).

Group II: Arm A (Control): ALND Active Control 1 Intervention

1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. ALND: Current standard of care, with the intention to remove the entire soft tissue within the anatomical borders of the axilla. 3. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223503/

Axillary Lymph Node Dissection for Breast Cancer The aim of this study was to assess the efficacy and complications of ALND in patients with breast cancer treated with mastectomy and breast-conserving surgery.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625004709

Comparing axillary dissection or not in breast cancer surgery The Risk of lymphedema is reduced by 65 % with sentinel node biopsy compared to axillary lymph node dissection, benefiting patients. •. No significant outcome ...

3. nature.com nature.com/articles/s41598-025-91405-1

The impact of axillary lymph node dissection on ... This study supports the omission of ALND in T1-2N1mi breast cancer patients undergoing mastectomy, demonstrating comparable survival outcomes to those ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1563586/full

Evaluating the survival outcomes in clinical node stage 2 ... This study aims to compare the oncologic outcomes of SNB alone versus SNB combined with axillary lymph node dissection (ALND) in this patient ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.70243

Trends and efficacy of omitting axillary lymph node ... SLNB and ALND provide comparable survival outcomes in early-stage MBC patients with limited lymph node metastasis undergoing radiotherapy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38368292/

Oncological Safety of Skipping Axillary Lymph Node ... Our findings suggest that SLNB could afford comparable outcomes to ALND in patients with early breast cancer and one to two metastatic SLNs who underwent TM.

7. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2805951

Safety of Targeted Axillary Dissection After Neoadjuvant ... In the TAD with ALND group, 8 deaths occurred, of which 6 were related to breast cancer, resulting in a 3-year OS of 91.9% (95% CI, 82.8-96.3) ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e12608

Outcomes from targeted axillary lymph node dissection ... Conclusions: ALND was avoided in approximately half of patients who presented with axillary node metastases and became ycN0 post-NAC. Over 50% ...