A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

  • End date
    Feb 13, 2023
  • participants needed
  • sponsor
Updated on 12 December 2021
breast cancer
triple negative breast cancer


This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer


This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.

Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

Condition Triple Negative Breast Neoplasms
Treatment Selumetinib, Paclitaxel, durvalumab, Capivasertib, oleclumab, Trastuzumab deruxtecan, Danvatirsen, Datopotamab deruxtecan
Clinical Study IdentifierNCT03742102
Last Modified on12 December 2021


Yes No Not Sure

Inclusion Criteria

At least 18 years of age at the time of screening
Patient must have locally confirmed advanced/unresectable or metastatic TNBC
No prior treatment for metastatic (Stage IV) TNBC
Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
WHO/ECOG status at 0 or 1 at enrollment
Patients enrolled to Arm 6 (durvalumab and DS-8201a) Must provide documentation of locally
determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC
+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

Exclusion Criteria

Active infection including tuberculosis, hepatitis B (known positive HBV surface
History of allogeneic organ transplantation
antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus
Active or prior documented autoimmune or inflammatory disorders
(positive HIV 1/2 antibodies)
Known allergy or hypersensitivity to any of the study drugs or any of the study drug
Untreated CNS metastases
Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
Female patients who are pregnant, breastfeeding
Patients enrolled in Arm 2 only
Cardiac Ejection Fraction less than 50%
Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or
History of or active interstitial lung disease/pneumonitis
CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's
Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Patients enrolled in Arm 6 and 7 only
such as heart failure, hypokalemia, potential for torsades de pointes, congenital long
QT syndrome, family history of long QT syndrome or unexplained sudden death under 40
Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm
years of age, or any concomitant medication known to prolong the QT interval
Prior treatment with PI3K inhibitors, AKT inhibitors, or mammalian target of rapamycin
(mTOR) inhibitors
Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months
Patients enrolled in Arm 7 only: Clinically significant corneal disease in the opinion of
the Investigator
) or Dato-DXd (DS-1062a; Arm 7) treatment
Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received
HER2-targeted therapy
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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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