Basket study for oligo-metastatic breast cancer - ANISE

Conditions

breast cancer, HER2-positive, oligometastatic disease

Brief summary

Complete radiologic response as defined by RECIST1.1

Detailed description

Complete radiologic response as defined by RECIST1.1 along with clearance of ctDNA, PFS as defined by RECIST 1.1., Pathological complete response in patients undergoing resection of primary tumor and/or metastatic lesions after neo-adjuvant treatment, Complete metabolic response as defined by EORTC guidelines, Preplanned loco-regional treatment performed without treatment related delay (window of 3 weeks), Incidence and severity of adverse events (CTCAE v5.0) until 30 days after last treatment administration. Incidence and severity of interstitial lung disease (ILD), Incidence and severity of adverse events grade ≥3 (CTCAE v5.0 or Clavien-Dindo in case of surgical resection) until 30 days after last treatment administration in relation to local therapy

Related papers

No related papers found yet.

Interventions

DRUGDS-8201a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete radiologic response as defined by RECIST1.1	—

Secondary

Measure	Time frame
Complete radiologic response as defined by RECIST1.1 along with clearance of ctDNA, PFS as defined by RECIST 1.1., Pathological complete response in patients undergoing resection of primary tumor and/or metastatic lesions after neo-adjuvant treatment, Complete metabolic response as defined by EORTC guidelines, Preplanned loco-regional treatment performed without treatment related delay (window of 3 weeks), Incidence and severity of adverse events (CTCAE v5.0) until 30 days after last treatment administration. Incidence and severity of interstitial lung disease (ILD), Incidence and severity of adverse events grade ≥3 (CTCAE v5.0 or Clavien-Dindo in case of surgical resection) until 30 days after last treatment administration in relation to local therapy	—

Measure

Time frame

Complete radiologic response as defined by RECIST1.1 along with clearance of ctDNA, PFS as defined by RECIST 1.1., Pathological complete response in patients undergoing resection of primary tumor and/or metastatic lesions after neo-adjuvant treatment, Complete metabolic response as defined by EORTC guidelines, Preplanned loco-regional treatment performed without treatment related delay (window of 3 weeks), Incidence and severity of adverse events (CTCAE v5.0) until 30 days after last treatment administration. Incidence and severity of interstitial lung disease (ILD), Incidence and severity of adverse events grade ≥3 (CTCAE v5.0 or Clavien-Dindo in case of surgical resection) until 30 days after last treatment administration in relation to local therapy

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Countries

France, Italy, Netherlands, Spain, Sweden

Outcome results

None listed