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Closed (no longer recruiting)Last updated: 14 May 2024

Impassion 030: This phase III trial is comparing the safety and effectiveness of an immunotherapy drug (Atezolizumab) and a chemotherapy drug (Paclitaxel), given in combination with the investigator's choice of standard chemotherapy, for the treatment of stage II or stage III triple negative breast cancer (TNBC)A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

Clinical summary

Summary

Eligible participants will be randomised to receive chemotherapy alone; OR in combination with atezolizumab (IV, 840 mg), every two weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose. For both Arms, chemotherapy will consist of paclitaxel (IV, 80mg/m^2) every week for 12 weeks, followed by dose-dense doxorubicin and cyclophosphamide or dose-dense epirubicin and cyclophosphamide, every 2 weeks for 4 doses.

Conditions

This trial is treating patients with triple negative breast cancer (TNBC)

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

Impassion 030

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has not spread to other parts of the body.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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