Tailored Axillary Surgery and Radiotherapy for Breast Cancer

(TAXIS Trial)

Recruiting at 84 trial locations

Overseen By Walter P. Weber, Prof.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Must not be taking: Experimental drugs

Disqualifiers: Stage IV breast cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best treatment for breast cancer by comparing two approaches to surgery and radiotherapy (also known as radiation therapy or X-ray therapy). It focuses on removing only the affected lymph nodes to avoid unnecessary complications from more invasive surgery. Participants will undergo tailored axillary surgery followed by either full or partial lymph node removal and regional radiotherapy. Women and men with node-positive breast cancer, detectable by imaging or touch and confirmed by pathology, may be suitable candidates for this trial. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking any experimental drugs, you must stop them at least 30 days before joining the trial.

What prior data suggests that tailored axillary surgery and radiotherapy are safe for breast cancer patients?

Research shows that tailored axillary surgery is generally safe and well-tolerated for breast cancer patients. One study found that only 2.3% of patients experienced cancer returning in the treated area after 44 months, meaning that for most patients, the cancer did not recur there.

Another study reported that 91.9% of patients were still alive three years after the surgery, indicating positive long-term outcomes with this procedure.

Although some deaths occurred in a group that also underwent more extensive lymph node surgery, most were due to breast cancer, not the surgery itself. Overall, tailored axillary surgery reduces unnecessary complications and is safe, with good long-term results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to treating breast cancer by tailoring axillary surgery and radiotherapy. Unlike the standard treatment, which often involves comprehensive axillary lymph node dissection (ALND), this trial examines the effectiveness of a more targeted surgical technique followed by selective radiation. The "No ALND" approach aims to minimize surgical intervention and focus on irradiating the full axilla, potentially reducing side effects and improving recovery times. Meanwhile, the "ALND" approach refines the use of axillary lymph node dissection by excluding the dissected area from irradiation, possibly offering a balance between thorough treatment and reduced radiation exposure. Researchers hope these strategies will offer effective cancer control with fewer complications.

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

This trial compares two approaches to underarm surgery for breast cancer. One approach involves tailored axillary surgery followed by regional nodal irradiation, including the full axilla. The other involves tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation, excluding the dissected axilla. Studies have shown that a personalized approach to underarm surgery can effectively treat breast cancer with fewer side effects. Research indicates that this method avoids unnecessary surgery by removing only lymph nodes affected by cancer, reducing complications while still effectively treating the disease. Previous patients demonstrated promising results, with the procedure accurately identifying cancer about 90% of the time. This approach aims to improve patients' quality of life by reducing the impact of surgery. ^{3 5 6 7 8}

Who Is on the Research Team?

Walter P. Weber, Prof.

Principal Investigator

University Hospital, Basel, Switzerland

Are You a Good Fit for This Trial?

The TAXIS trial is for adults with node-positive breast cancer, confirmed by touch or imaging. It's open to those who can fill out quality of life surveys and includes new cases or isolated in-breast recurrences after prior treatment without axillary surgery or radiation. People with occult breast cancer are eligible if they have biopsy-proven lymphatic metastasis.

Inclusion Criteria

My cancer has spread to my lymph nodes, confirmed by tests.

My cancer has spread to lymph nodes in my armpit, confirmed by a doctor's exam and lab tests.

My condition was recently diagnosed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tailored axillary surgery followed by either axillary lymph node dissection or regional nodal irradiation

6-8 weeks

Follow-up

Participants are monitored for disease-free survival, adverse events, and overall survival

20 years

Long-term monitoring

Participants are assessed for late radiotherapy-related adverse events and surgical site infections

20 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiotherapy
• Tailored Axillary Surgery

Trial Overview This phase III trial tests tailored axillary surgery followed by radiotherapy versus the same surgery without subsequent radiotherapy. The goal is to see if targeted removal of affected lymph nodes provides similar effectiveness while improving quality of life compared to more radical approaches.

How Is the Trial Designed?

Group I: No ALND Active Control 2 Interventions

Tailored axillary surgery followed by regional nodal irradiation including the full axilla.

Group II: ALND Active Control 2 Interventions

Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

ETOP IBCSG Partners Foundation

Collaborator

Trials

66

Recruited

58,200+

Austrian Breast Cancer Study Group

Collaborator

Trials

1

Recruited

1,500+

Published Research Related to This Trial

Occult breast cancer that presents as axillary metastasis is rare and poses significant diagnostic and treatment challenges, with current management strategies being highly variable across different regions.

Recent findings suggest that breast preservation with adjuvant whole breast radiotherapy can provide equivalent local control and survival compared to traditional modified radical mastectomy, indicating a shift towards less invasive treatment options for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-escalation of surgery for occult breast cancer with axillary metastasis. Holt, AC., Haji, F., McCloskey, S., et al.[2023]

Endoscopic axillary lymphadenectomy using needlescopic instruments was successfully performed on 5 breast cancer patients, with no intra- or postoperative complications reported, indicating a high safety profile for this technique.

The procedure had a mean operation time of 105.4 minutes and minimal blood loss (19.4 ml), suggesting it is an effective and less invasive option for lymph node removal in breast cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with endoscopic axillary lymphadenectomy using needlescopic instruments in patients with breast cancer: a preliminary report. Tagaya, N., Kubota, K.[2004]

In a study of 8089 mastectomy patients with tumor-positive lymph nodes, 30.7% underwent sentinel lymph node biopsy (SNB) alone, and those patients were 1.70 times more likely to receive postmastectomy chest wall radiation therapy (PMRT) compared to those who had axillary lymph node dissection (ALND).

The findings suggest that surgeons are increasingly opting for SNB alone in early-stage, node-positive breast cancer patients, which may influence the subsequent need for PMRT, highlighting a shift in surgical practice that could impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary Surgery for Early-Stage, Node-Positive Mastectomy Patients and the Use of Postmastectomy Chest Wall Radiation Therapy. Gaines, S., Suss, N., Barrera, E., et al.[2019]

In a study involving 4823 patients with T1-2 primary breast cancer, axillary radiotherapy provided comparable control of axillary recurrence to axillary lymph node dissection, with 5-year recurrence rates of 1.19% for radiotherapy versus 0.43% for dissection.

Axillary radiotherapy was associated with significantly lower rates of lymphoedema compared to axillary lymph node dissection, indicating it may be a safer option with fewer side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Donker, M., van Tienhoven, G., Straver, ME., et al.[2022]

In a study of 1,815 breast cancer patients, those who underwent axillary lymph node dissection (ALND) alone had a significantly higher risk of developing breast cancer-related lymphedema (BCRL) compared to those who had sentinel lymph node biopsy (SLNB) alone, with a hazard ratio of 2.66.

While regional lymph node radiation (RLNR) increased the risk of lymphedema, the type of axillary surgery was the primary risk factor, indicating that SLNB is a safer option for minimizing BCRL risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the Impact of Axillary Surgery and Nodal Irradiation on Breast Cancer-Related Lymphedema and Local Tumor Control: Long-Term Results From a Prospective Screening Trial. Naoum, GE., Roberts, S., Brunelle, CL., et al.[2021]

In a study involving 500 patients with clinical node-positive breast cancer, imaging-guided localization (IGL) was used in 84.4% of cases during tailored axillary surgery (TAS), but it did not significantly affect the number of lymph nodes removed or the amount of residual cancer found after surgery.

The results showed that while IGL was widely used, it did not lead to a significant difference in the effectiveness of TAS compared to traditional methods, indicating that IGL may not be necessary for improving surgical outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101). Weber, WP., Heidinger, M., Hayoz, S., et al.[2023]

In a study of 220 women with isolated axillary recurrence of breast cancer, a combination of surgery and radiation significantly improved overall survival and disease-free survival rates, highlighting the importance of multimodal treatment strategies.

The 5-year overall survival rate after axillary recurrence was 49.3%, with better outcomes associated with longer intervals between the initial diagnosis and recurrence, no prior axillary radiation, and asymptomatic presentations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management and outcomes of isolated axillary node recurrence in breast cancer. Konkin, DE., Tyldesley, S., Kennecke, H., et al.[2006]

Axillary surgery is crucial in breast cancer management for accurate staging, treatment, and determining the number of metastatic lymph nodes, which influences prognosis and adjuvant therapy decisions.

Complete axillary clearance is recommended for optimal outcomes, as less radical procedures may lead to understaging, which can negatively impact patient survival and locoregional tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary surgery in breast cancer management--background, incidence and extent of nodal spread, extent of surgery and accurate axillary staging, surgical procedures. Blichert-Toft, M.[2019]

In a study of 282 women with clinically node-negative breast cancer, 27% were found to have pathologically positive nodes after axillary dissection, indicating that this procedure can reveal previously undetected cancer spread.

Axillary dissection significantly influenced treatment recommendations, particularly for women under 60 years old, with notable shifts in therapy for those with tumors less than 1 cm and those with positive prognostic features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does information from axillary dissection change treatment in clinically node-negative patients with breast cancer? An algorithm for assessment of impact of axillary dissection. Dees, EC., Shulman, LN., Souba, WW., et al.[2019]

The tailored axillary surgery (TAS) effectively reduced axillary tumor load in patients with clinically node-positive breast cancer, with a median removal of five nodes, two of which were positive, while maintaining a low false-negative rate of 2.6%.

In a study of 296 patients across 28 sites, TAS demonstrated a less radical approach compared to axillary lymph node dissection (ALND), allowing for targeted treatment while still achieving significant tumor reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101). Weber, WP., Matrai, Z., Hayoz, S., et al.[2021]

A systematic review of 26 randomized controlled trials involving 7,460 participants found that sentinel lymph node biopsy (SLNB) and axillary sampling are effective alternatives to axillary lymph node dissection (ALND) for staging breast cancer, with similar overall survival rates and significantly lower risks of lymphoedema.

The review also indicated that omitting axillary surgery altogether may not significantly impact overall survival compared to ALND, but it does increase the risk of locoregional recurrence, highlighting the importance of careful consideration in surgical decisions for breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axillary treatment for operable primary breast cancer. Bromham, N., Schmidt-Hansen, M., Astin, M., et al.[2022]

The TAXIS trial is exploring whether axillary lymph node dissection (ALND) can be safely omitted in clinically node-positive breast cancer patients, focusing on tailored axillary surgery (TAS) and its impact on disease-free survival, morbidity, and quality of life.

With 663 out of 1500 patients already randomized, the trial aims to provide insights into surgical de-escalation for high-risk patients, potentially reducing the negative impacts associated with traditional ALND.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored axillary surgery - A novel concept for clinically node positive breast cancer. Heidinger, M., Knauer, M., Tausch, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11799411/

Design Paper: A Prospective, Multicenter, Single-arm, Phase II ... This approach aims to enhance breast cancer management by reducing surgical burden and improving the patient outcomes. jRCTs: 061220113.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS611

Tailored axillary surgery with or without axillary lymph node ... The TAXIS trial was designed to investigate if axillary radiotherapy (ART) can replace ALND in patients with cN+ BC who underwent tailored axillary surgery ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03513614

Study Details | NCT03513614 | Tailored Axillary Surgery ... TAS is a promising procedure that may significantly decrease morbidity in breast cancer patients by avoiding surgical overtreatment. This trial has the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11083357/

Axillary Surgery for Breast Cancer in 2024 - PMC Whilst showing a false-negative rate of around 10%, excellent oncologic outcomes were achieved [5,6,7,8]. Notably, SLNB dramatically reduced ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960977621004586

Tailored axillary surgery in patients with clinically node- ... We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034500/

Tailored axillary surgery – A novel concept for clinically ... Recently, published data from the MARI trial reported axillary pCR rates of 9%, 59%, 94%, and 54% in luminal breast cancer, HR-positive/Her2- ...

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

Evaluating the survival outcomes in clinical node stage 2 ... Results: Over a median follow-up of 44 months, the overall axillary recurrence rate was 2.3%, and the univariate and multivariate analyses ...