Trial Title:
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)
NCT ID:
NCT05573555
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
TACTIVE-U; Umbrella study; PROTAC; metastatic breast cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1b will use an escalation/de-escalation approach to determine the RP2D of ARV-471
when administered in combination with ribociclib. The decision to escalate the starting
dose level of ARV-471 will be using mTPI-2 decision criteria based on the number of
DLT-evaluable participants and the number of DLTs in those participants during the DLT
observation period (Cycle 1).
During Phase 1b, a 7 days lead-in period will be conducted with ARV-471 as monotherapy.
Phase 2 will further evaluate the preliminary antitumor activity and safety of the
combination RP2D.
In addition, the potential drug-drug interaction (DDI) between ARV-471 and ribociclib
will be evaluated, at the doses selected for the ph2 portion, in a DDI Assessment
Cohort(s)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ARV-471
Description:
Daily oral dosages of ARV-471 continuously, dose escalation/de-escalation in Phase 1b
until RP2D determined, cycles lasting 28 days
Arm group label:
ARV-471 in combination with Ribociclib
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
Daily oral dosages of ribociclib consecutively for 21 days followed by 7 days off
treatment, cycles lasting 28 days
Arm group label:
ARV-471 in combination with Ribociclib
Summary:
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called ARV-471) when given together with other medicines for the potential
treatment of advanced or metastatic breast cancer.
This study is seeking participants who have breast cancer that:
- is advanced, may have spread to other organs (metastatic) and cannot be fully
treated by surgery or radiation therapy
- is sensitive to hormonal therapy (it is called estrogen receptor positive); and
- is no longer responding to previous treatments
This study is divided into separate sub-studies.
For Sub-Study B:
All participants will receive ARV-471 and a medicine called ribociclib. ARV-471 and
ribociclib will be given at the same time by mouth, at home, 1 time a day.
The experiences of people receiving the study medicine will be examined. This will help
determine if the study medicine is safe and effective.
Participants will continue to take ARV-471 and ribociclib until their cancer is no longer
responding, or side effects become too severe. They will have visits at the study clinic
about every 4 weeks.
Detailed description:
C4891023 is a prospective, open-label, multicenter, Phase 1b/2 sub-study to evaluate the
safety, antitumor activity, and PK of ARV-471 with ribociclib in the treatment of
participants with A/MBC. The sub-study is part of Umbrella platform, TACTIVE-U,
comprising multiple sub-studies that independently evaluate ARV-471 in participants with
with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative
(ER+/HER2-) Advanced or Metastatic Breast Cancer. ARV-471 will act as the backbone
therapy given in combination with other anticancer agents thought to have clinical
relevance in ER+ breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast
cancer that is not amendable to surgical resection with curative intent (≥1% ER+
stained cells on the most recent tumor biopsy).
- prior anticancer therapies: at least 1 and no more than 2 lines of prior therapies
for advanced/metastatic disease; 1, and only 1, line of any CDK4/6 inhibitor-based
regimen is required (in any setting eg adjuvant, metastatic)
- at least 1 measurable lesion as defined by RECIST v1.1.
- ECOG PS ≤1.
Exclusion Criteria:
- visceral crisis at risk of life-threatening complications in the short term
- known history of drug-induced pneumonitis or other significant symptomatic
deterioration of lung functions.
- newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous
meningitis, or leptomeningeal disease. Participants with a history of CNS metastases
or cord compression are eligible if they have been definitively treated, clinically
stable and discontinued anti-seizure medications and corticosteroids for at least 14
days prior to enrollment in the of study.
- history of any other tumor malignancies within the past 3 years, except for the
following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2)
curatively treated in situ carcinoma of the cervix.
- inflammatory breast cancer
- impaired cardiovascular function or clinically significant cardiovascular diseases
- concurrent administration of medications, food, or herb supplements that are strong
inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to
Torsade de Pointes or QT interval prolongation.
- renal impairment, not adequate liver function and/or bone marrow function
- known active infection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Women's Cancer Center
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Medical Center at Mission Bay
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center - International Plaza
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt McKinley Hospital
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - WUPI
Address:
City:
Shiloh
Zip:
62269
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute - Chestnut Hill
Address:
City:
Newton
Zip:
02459
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - West County
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - North County
Address:
City:
Florissant
Zip:
63031
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes Jewish Hospital Department of Laboratories
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes-Jewish Hospital
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes Jewish Hospital Lab- South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Facility:
Name:
Siteman Cancer Center - St Peters
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Area Locations The Woodland
Address:
City:
Conroe
Zip:
77384
Country:
United States
Status:
Recruiting
Facility:
Name:
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
U.T. MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Area Locations MDACC West Houston
Address:
City:
Houston
Zip:
77079
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Area Locations MDACC League City
Address:
City:
League City
Zip:
77573
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Area Locations MDACC Sugarland
Address:
City:
Sugar Land
Zip:
77478
Country:
United States
Status:
Recruiting
Facility:
Name:
BC Cancer Vancouver
Address:
City:
Vancouver
Zip:
V5Z 1H7
Country:
Canada
Status:
Recruiting
Facility:
Name:
BC Cancer Vancouver
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sunnybrook Research Institute
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Facility:
Name:
CIUSSS- saguenay-Lac-Saint-Jean
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Humanitas Istituto Clinico Catanese
Address:
City:
Misterbianco
Zip:
95045
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria delle Marche
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Dexeus
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Start date:
March 1, 2023
Completion date:
January 6, 2027
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Arvinas Estrogen Receptor, Inc.
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05573555
https://pmiform.com/clinical-trial-info-request?StudyID=C4891023
