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New treatment option for Breast Cancer
Official title Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
ClinicalTrials.gov ID: NCT07140172
What this study is testing
- What it's testing
- This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- at screening:
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
- Patients ≥ 18 years of age.
- Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/...
- Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.
You likely can't join if
- at screening:
- Stage IV breast cancer.
- Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).
- Clinical N2b breast cancer (clinical N2a is allowed).
- Contralateral breast cancer within 3 years.
- Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).
See the full eligibility criteria
- at screening:
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
- Patients ≥ 18 years of age.
- Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/ International Union Against Cancer (AJCC/UICC) stage II-III (all molecular...
- Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.
- Node-positivity palpable (cN1-3) and confirmed by pathology.
- Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.
- Eligible for primary ALND or SLN procedure and either:
- Newly diagnosed.
- Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT.
- Upfront surgery setting.
- Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.)
- Ability to complete the QoL questionnaires.
- WHO performance status 0-2
- Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.
- Adult patients (≥18 years of age).
- Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and...
- Men agree not to father a child during trial treatment and for 6 months afterward.
- at screening:
- Stage IV breast cancer.
- Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).
- Clinical N2b breast cancer (clinical N2a is allowed).
- Contralateral breast cancer within 3 years.
- Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).
- Prior regional radiotherapy.
- Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months.
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin...
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect...
- Absence of clip in the specimen radiography.
- Palpable disease left behind in the axilla after TAS.
- No SLN identified in the axilla.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Dornbirn, Austria
- Feldkirch, Austria
- Innsbruck, Austria
- Linz, Austria
- Vienna, Austria
- Montreal, Canada
- Rijeka, Croatia
- Heidelberg, Germany
- Osnabrück, Germany
- Wuppertal, Germany
- Athens, Greece
- Heraklion, Greece
- Larissa, Greece
- Cork, Ireland
- Dublin, Ireland
- Galway, Ireland
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Durham, North Carolina, United States; Philadelphia, Pennsylvania, United States; Seattle, Washington, United States; Dornbirn, Austria; Feldkirch, Austria and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.