Clinical Trial 22617

• Overview

  Study Title:

  A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer

  Objective:

  Primary 1. To examine the feasibility of sequential therapy (ST) modeled on evolutionary dynamics in the treatment of MBC. Secondary 1. To explore preliminary efficacy of sequential therapy (ST) modeled on evolutionary dynamics in the treatment of MBC. 2. To evaluate and assess safety of Sequential ( First Strike, Second Strike ) Therapies. 3. To assess biomarkers in prediction of response. 4. To build and refine a Mathematical model of the first strike, second strike strategy based on clinical and biomarker data.

• Treatments

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  Abemaciclib (); DS-8201a (Trastuzumab Deruxtecan); Faslodex (fulvestrant); LEE011 (Ribociclib); LY2835219 (Abemaciclib); Ribociclib (); Sacituzumab Govitecan (); Taxotere (docetaxel); Trastuzumab Deruxtecan (); Xeloda (capecitabine); capecitabine (); cyclophosphamide (); cytoxan (cyclophosphamide); docetaxel (); fulvestrant ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Female patients 18 years or older
  • Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion
  • Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor)
  • Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range > Presence of measurable disease on imaging via RECIST v1.1
  • ECOG performance status 0-1
  • Participants must have adequate organ and marrow function as defined in the protocol
  • A negative pregnancy test for pre-menopausal women of childbearing potential
  • Pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation
  • Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below exclusion criteria are eligible for this trial
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant’s behalf
  • Additional Criteria will apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Have previously received Fulvestrant for treatment of their breast cancer
  • History of allergic reactions attributed to the study drugs
  • Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Uncontrolled intercurrent illness including—but not limited to—ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with advanced, symptomatic visceral spread, that are at risk of life threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA
  • Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan)
  • Inability to comply with protocol requirements
  • Pregnant and/or breastfeeding women are excluded
  • Additional Criteria will apply

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