IMpassion30/WO39391 : A phase III, multicenter, randomized, open-label study comparing atezolizumab (anti-PDL1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone in patients with operable triple-negative breast cancer
Indication :

Cancer du sein, triple-négatif


Sponsor :

Roche


Phase :

III


Ligne :

1


Traitement :

Atezolizumab (anti-PDL1 antibody) in combination with adjuvant anthracycline/taxane-based chemotherapy versus chemotherapy alone


Spécificités :

Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy.


Site :

CHUV


Contact(s) :
Khalil Zaman
Investigateur Principal

CHUV
Oncologie Médicale

Rue du Bugnon 46
Lausanne
1011

0213147905
khalil.zaman@chuv.ch

Primary objective :

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide (referred to as atezolizumab+T-AC/EC) compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone (referred to as T-AC/EC) in patients with Stage II−III TNBC.


Inclusion criteria :

Ages Eligible for Study: 18 Years and older
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

Non-metastatic operable Stage II-III breast cancer
Histologically documented TNBC (Triple Negative Breast Cancer)
Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.


Exclusion criteria :

Prior history of invasive breast cancer
For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
Previous therapy with anthracyclines or taxanes for any malignancy
Cardiopulmonary dysfunction
Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Urinary outflow obstruction
Active tuberculosis
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
Prior allogeneic stem cell or solid organ transplant
Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study