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TACTIVE-U: An Umbrella Study to Investigate the Safety and Antitumor Activity of ARV-471 in Combination With Other Medicines in Adults With ER+ Advanced or Metastatic Breast Cancer, Sub-study B (ARV-471 and Ribociclib)
EU CTIS ID: 2022-502231-19-00
What this study is testing
Phase 1b: To assess safety and tolerability of ARV-471 in combination with ribociclib in participants with ER+/HER2- A/MBC to select a RP2D. DDI Assessment Cohort(s): To evaluate the effect of ARV-471 on PK of ribociclib. Phase 2: To assess the clinical antitumor activity of ARV-471 in combination with ribociclib.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
- Histological or cytological diagnosis of ER+ and HER2- A/MBC 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 one and no more than to 2 lines of prior therapies for advanced/metastatic disease - 1 and only 1, line of any prior CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic). If prior CDK4/6 inhibitor was permanently discontinued due to an adverse event, the participant will not be eligible. If prior CDK4/6 inhibitor required dose reductions due to an adverse event, refer to Section 6.9.1 for the eligibility evaluation.
- Participants must have at least 1 measurable lesion as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
You likely can't join if
- Participants in visceral crisis at risk of life-threatening complications in the short term.
- Participants with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
- Participants with 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.
- History of any other 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. All other malignancies must have been curatively treated and with no evidence of disease for >3 years. Participants with inflammatory breast cancer are excluded.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong inducers of CYP3A, and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
See the full eligibility criteria
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
- Histological or cytological diagnosis of ER+ and HER2- A/MBC 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 one and no more than to 2 lines of prior therapies for advanced/metastatic disease - 1 and only 1, line of any prior CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic). If prior CDK4/6 inhibitor was permanently discontinued due to an adverse event, the participant will not be eligible. If prior CDK4/6 inhibitor required dose reductions due to an adverse event, refer to Section 6.9.1 for the eligibility evaluation.
- Participants must have at least 1 measurable lesion as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Participants in visceral crisis at risk of life-threatening complications in the short term.
- Participants with a known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
- Participants with 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.
- History of any other 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. All other malignancies must have been curatively treated and with no evidence of disease for >3 years. Participants with inflammatory breast cancer are excluded.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong 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 including HBV, HCV, and HIV or AIDS-related illness.
- In addition, for participants to be enrolled in the DDI Assessment Cohort(s): moderate CYP3A inhibitors and inducers are also prohibited to avoid potential impact on DDI analysis.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.