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Clinical Trial 20152

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03997123

Phase: Phase III
Prinicipal Investigator: Aixa Soyano Muller

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Overview

Study Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC)

Summary

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC)

Objective

To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS. To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by assessment of OS. Secondary: To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS. To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS2.

Treatments

Therapies

Medications

Capivasertib (); Placebo (); Taxol (paclitaxel); paclitaxel ()

Inclusion Criteria

Inclusion Criteria:

  • Histologically confirmed TNBC from most recently collected tumour tissue sample
  • Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
  • Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease
  • FFPE tumour sample from primary/recurrent cancer

  • Exclusion Criteria

    Exclusion Criteria:

  • Prior chemotherapy in the (neo)adjuvant setting within 12 months from the end of chemotherapy to inclusion into this study
  • Prior systematic therapy for inoperable locally advanced or metastatic disease
  • Prior treatment with any of the following: AKT, PI3K, and/or mTOR inhibitors, Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study), Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor.
  • Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week prior to the first dose of study treatment.
  • Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
  • Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
  • With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
  • Cardiac criteria per protocol.
  • Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening: Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment, HbA1c ≥8.0% (63.9 mmol/mol)
  • Inadequate bone marrow reserve or organ function at screening
  • Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

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