A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE ) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    145
  • sponsor
    Arvinas Inc
Updated on 26 January 2021
estrogen
measurable disease
growth factor
endocrine therapy
hormone therapy
advanced breast cancer
epidermal growth factor receptor
HER2
EGFR
stage iv breast cancer
erbb2
epidermal growth factor
estrogen receptor
palbociclib
immunostimulant

Summary

This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety and tolerability of ARV-471 alone and in combination with palbociclib (IBRANCE) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment ARV-471, ARV-471 in combination with palbociclib (IBRANCE®)
Clinical Study IdentifierNCT04072952
SponsorArvinas Inc
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients at least 18 years of age at the time of signing the informed consent
Part A
Patients must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy
Patients must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer for which standard curative therapy is no longer effective or does not exist
Patients must be willing to undergo a biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER IHC testing and PD studies. (Patients without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)
Patients must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting
Women must be postmenopausal due to surgical or natural menopause
Part B
Patients must have received at least 1 prior endocrine regimen for a minimum of 6 months in the locally advanced or metastatic setting; if more than 1 prior endocrine regimen has been administered, only one of the regimens must have been administered for a minimum of 6 months in the locally advanced or metastatic setting
Patients must have received a CDK4/6 inhibitor
Patients must have received 1 prior regimen of cytotoxic chemotherapy in the locally advanced or metastatic setting
Women must be postmenopausal due to surgical or natural menopause
Part C
Patients must have received no more than one prior endocrine therapy in the advanced setting unless the patient recurred during adjuvant treatment or within the 12 months of completion of adjuvant endocrine therapy in which case no prior endocrine therapy is required in the advanced setting
Patients must have received no more than one prior chemotherapy regimen for advanced disease
Women must be postmenopausal due to surgical or natural menopause

Exclusion Criteria

Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to first dose of study drug, have discontinued high-dose corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable as judged by the Investigator
Patients who have received 4 or more regimens of chemotherapy for locally advanced or mBC
Receipt of prior anti-cancer or other investigational therapy within 14 days prior to the first administration of study drug
Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
Part A
Part B
Patients who have received more than 1 regimen of chemotherapy for locally advanced or mBC
Part C
Patients have received more than one regimen of chemotherapy for advanced/metastatic disease (regardless of prior adjuvant chemotherapy use) in addition to endocrine therapy
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