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

  • STATUS
    Recruiting
  • End date
    Feb 13, 2023
  • participants needed
    200
  • sponsor
    AstraZeneca
Updated on 29 August 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (1.0 mi away) Contact
+64 other location
paclitaxel
cancer
breast cancer
HER2
trastuzumab
antineoplastic
triple negative breast cancer
erbb2

Summary

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

Description

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.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Triple Negative Breast Neoplasms, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Selumetinib, Paclitaxel, durvalumab, Capivasertib, oleclumab, Trastuzumab deruxtecan, Danvatirsen, Datopotamab deruxtecan
Clinical Study IdentifierNCT03742102
SponsorAstraZeneca
Last Modified on29 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female
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 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH
untested)

Exclusion Criteria

Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders
Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
Untreated CNS metastases
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
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 CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
History of or active interstitial lung disease/pneumonitis
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, 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 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
months
Patients enrolled in Arm 7 only: Clinically significant corneal disease in the
opinion of the Investigator
Patients enrolled in Arm 6 and 7 only
Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm
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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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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