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.
- Brief Title: Clinical Trial of ARV-471 in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
- Official Title: A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 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
Clinical Trial IDs
- ORG STUDY ID:
- NCT ID:
This is a first in human, dose escalation study and will assess the safety and tolerability
of ARV-471 in woman and men with ER+/HER2- locally advanced or metastatic breast cancer, who
have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic
- Patients at least 18 years of age at the time of signing the informed consent.
- Patients must have histologically or cytologically confirmed ER+ and HER2- advanced
breast cancer. Advanced breast cancer is metastatic, recurrent, or locally advanced
unresectable breast cancer for which standard curative therapy is no longer effective
or does not exist.
- 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 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. All
such therapy must be discontinued at least 14 days prior to enrollment.
- 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 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
- 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.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Measure:||Incidence of Dose Limiting Toxicities of ARV-471|
|Time Frame:||28 Days|
|Description:||First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug|
|Lead Sponsor:||Arvinas Inc|
- Breast Cancer
- Metastatic Breast Cancer
- Malignant Neoplasm of the Breast
- Locally Advanced Breast Cancer