OPBC-03 / SAKK 23/16 / IBCSG 57-18 / ABCSG-53: Surgical axillary lymph node removal with the option of "extended surgery" or "radiotherapy" in breast cancer patients with existing lymph node involvement in the axilla.

ID di studio ICTRP
NCT03513614 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
non disponibile

Titolo accademico
Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS). A Multicenter Randomized Phase III Trial (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101) (ICTRP)

Titolo pubblico
Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS) (ICTRP)

Malattie studiate
Node-positive Breast Cancer (ICTRP)

Intervento studiato
Procedure: Tailored axillary surgery - both Arms;Radiation: Radiotherapy - Arm A;Radiation: Radiotherapy - Arm B (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

Inclusion criteria at pre-registration:

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

- Breast cancer, node positive detected by palpation or imaging (with or without
planned neoadjuvant treatment)

- Female or male aged = 18 years

- Ability to complete the Quality of Life questionnaires

Inclusion criteria at registration:

- Node-positive breast cancer (histologically or cytologically proven both in primary
tumor and in lymph node) AJCC/UICC [42] stage II-III (all molecular subtypes
allowed):

- Node-positivity detected by imaging (iN+) and confirmed by pathology

- Node-positivity detected by palpation (cN1-3) and confirmed by pathology

- Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis
is present

- Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section
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

- Most suspicious axillary lymph node clipped

- Baseline Quality of Life questionnaire has been completed

- WHO performance status 0-2

- Adequate condition for general anesthesia and breast cancer surgery

- Women with child-bearing potential are using effective contraception, are not
pregnant or lactating and agree not to become pregnant during trial treatment and
thereafter during the time recommended by the guidelines for adjuvant systemic
therapies. A negative pregnancy test before inclusion into the trial is required for
all women with child-bearing potential.

- Men agree not to father a child during trial treatment and thereafter during 6
months.

Inclusion criteria at randomization (intraoperatively)

- Node-positive breast cancer (histologically or cytologically proven both in primary
tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed):

- Node-positivity initially detected by imaging and non-palpable and residual
disease confirmed by pathology** (including residual ITCs) in SLN or non SLN in
case of prior neoadjuvant treatment

- Node-positivity initially palpable and residual disease confirmed by
pathology** (including residual ITCs) in case of prior neoadjuvant treatment

- Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers
to the stage before neoadjuvant treatment) **Note: If the fine needle
aspiration or core biopsy of the clipped node after neoadjuvant treatment
unequivocally shows cancer, repeated confirmation of residual disease by
intraoperative frozen section is not mandatory

Exclusion Criteria:

Exclusion criteria at pre-registration:

Any potential patient who meets any of the following criteria has to be excluded from
entering the trial.

- Stage IV breast cancer

- Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed)

- Clinical N2b breast cancer (clinical N2a is allowed)

- Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In
Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the
trial treatment

- Prior axillary surgery (except prior sentinel node procedure in case of in- breast
recurrence)

- Prior regional radiotherapy

- 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 cancer.

- Treatment with any experimental drug within 30 days of pre-registration

- 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 patient compliance or place the
patient at high risk from treatment-related complications.

Exclusion criteria at randomization (intraoperatively):

Any potential patient who meets any of the following criteria has to be excluded from the
trial.

- Absence of clip in the specimen radiography

- Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS)

- No SLN identified in the axilla (ICTRP)

non disponibile

Endpoint primari e secondari
Disease-free survival (DFS) (ICTRP)

Overall survival (OS);Breast cancer-specific survival (BCSS);Time to local recurrence (TTLR);Time to distant recurrence (TTDR);Physician reported morbidity outcomes (Lymphedema);Physician reported morbidity outcomes (Decreased range of shoulder motion);Adverse events according to NCI CTCAE v4.03;Late radiotherapy-related adverse events;Surgical site infections (SSI) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
ETOP IBCSG Partners Foundation;Austrian Breast Cancer Study Group (ICTRP)

Contatti aggiuntivi
Walter P. Weber, Prof.;Walter P. Weber, Prof., walter.weber@usb.ch, +41 61 328 61 49, University Hospital, Basel, Switzerland, (ICTRP)

ID secondari
2018-000372-14, 2018-00838, ch20Weber2 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03513614 (ICTRP)