Tailored Axillary Surgery and Radiotherapy for Breast Cancer

(TAXIS Trial)

Recruiting in Palo Alto (17 mi)

+67 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Hospital, Basel, Switzerland

Must not be taking: Experimental drugs

Disqualifiers: Stage IV breast cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy. PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.

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 data supports the effectiveness of the treatment Tailored Axillary Surgery and Radiotherapy for Breast Cancer?

The TAXIS trial is investigating if tailored axillary surgery (removing specific lymph nodes) followed by radiotherapy can safely replace more extensive surgery in breast cancer patients with positive lymph nodes. Early results show this approach is feasible and aims to maintain disease-free survival while reducing side effects and improving quality of life compared to traditional surgery. ^{1 2 3 4 5}

Is tailored axillary surgery and radiotherapy safe for humans?

Tailored axillary surgery followed by radiotherapy is being studied for its safety and effectiveness in treating breast cancer, with a focus on reducing harmful side effects compared to traditional surgery. Early studies suggest it may have fewer side effects than standard axillary lymph node dissection, which is known for causing issues like lymphedema (swelling due to lymph fluid buildup). ^{4 6 7 8 9}

How is the treatment Tailored Axillary Surgery different from other treatments for breast cancer?

Tailored Axillary Surgery (TAS) is unique because it focuses on reducing the tumor volume in the armpit area to a level where radiotherapy can effectively control it, unlike traditional methods that may involve more extensive surgery. This approach involves removing only the sentinel lymph nodes and any suspicious nodes, which can help minimize the side effects associated with more invasive surgeries. ^{1 6 10 11 12}

Research Team

Walter P. Weber, Prof.

Principal Investigator

University Hospital, Basel, Switzerland

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Radiotherapy (Radiation)
• Tailored Axillary Surgery (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.

Participant Groups

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+

Dr. Rakesh Padiyath

University Hospital, Basel, Switzerland

Chief Executive Officer

MD, MBA

Prof. Dr. Daniel Staub

University Hospital, Basel, Switzerland

Chief Medical Officer

MD

ETOP IBCSG Partners Foundation

Collaborator

Trials

66

Recruited

58,200+

Rolf A. Stahel

ETOP IBCSG Partners Foundation

Chief Executive Officer since 2020

MD from University of Zürich

Solange Peters

ETOP IBCSG Partners Foundation

Chief Medical Officer since 2023

MD and PhD from University Hospital of Lausanne

Austrian Breast Cancer Study Group

Collaborator

Trials

1

Recruited

1,500+

Findings from Research

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]

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]

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]

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]

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 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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Axillary treatment for operable primary breast cancer. [2022]

2. England 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. [2019]

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

Management and outcomes of isolated axillary node recurrence in breast cancer. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Tailored axillary surgery - A novel concept for clinically node positive breast cancer. [2023]

5. United States 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. [2019]

6. Netherlands 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). [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2021]

9. England 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. [2022]

10. United States 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). [2023]

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

Axillary Surgery for Early-Stage, Node-Positive Mastectomy Patients and the Use of Postmastectomy Chest Wall Radiation Therapy. [2019]

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

De-escalation of surgery for occult breast cancer with axillary metastasis. [2023]