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Small Molecule Inhibitor

ARRY-380 + Trastuzumab for Breast Cancer

Phase 1
Waitlist Available
Led By Nancy Lin, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New or progressive CNS lesions, as assessed by the patient's treating physician.
Participants who have not previously been treated with cranial radiation (e.g. WBRT or SRS) are eligible to enter the study, but such participants must be asymptomatic from their CNS metastases and not requiring corticosteroids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test the safety of different doses of ARRY-380 in combination with trastuzumab to see if the combination is safe for people to take.

Who is the study for?
This trial is for adults with HER2-positive invasive breast cancer that has spread to the brain. Participants must have had prior treatments like trastuzumab, be in good physical condition (ECOG 0-2), and not have received certain therapies recently. They should not be pregnant or breastfeeding and must agree to use contraception. People with severe allergies to similar drugs, uncontrolled illnesses, or a history of other active cancers within the last two years are excluded.Check my eligibility
What is being tested?
The study tests different doses of ARRY-380 combined with FDA-approved trastuzumab for treating HER2 metastatic breast cancer that has spread to the brain. The combination aims to block overactive HER2 receptors more effectively by attaching at different sites, potentially targeting cancer cells while sparing normal ones.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions may include allergic responses due to drug composition similarities between ARRY-380 and trastuzumab. Other potential risks could involve organ inflammation from immune reactions, fatigue from treatment stress on the body, digestive issues as off-target effects, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have new or growing lesions in your brain, as determined by your doctor.
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You have not received radiation treatment to the head before, and if you have cancer that has spread to the brain, you do not have symptoms and do not need corticosteroids.
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You are able to perform daily activities without much difficulty.
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You can have been treated with trastuzumab or lapatinib before, and there's no limit to how many treatments you've had before.
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You must have a brain lesion that can be accurately measured and is at least 10 millimeters in size.
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You can participate if you had brain surgery before, as long as there are still measurable or growing lesions in your brain.
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You haven't increased your corticosteroid dose in the week before the brain MRI.
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You can still participate if you had certain types of radiation treatment before and your condition got worse afterwards.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine Maximum-tolerated dose of ARRY-380 with Trastuzumab
Secondary outcome measures
CNS Response according to modified RECIST 1.1
CNS objective response rate according to volumetric criteria
Clinical benefit (CR, PR, or SD>/=24 weeks)
+4 more

Trial Design

2Treatment groups
Active Control
Group I: ARRY-380 Twice Daily DosageActive Control2 Interventions
ARRY-380 will be 450mg orally twice-daily. Trastuzumab will be given at the standard full dose with a loading dose of 8 mg/kg on Day 1, cycle 1, followed by 6 mg/kg in subsequent cycles. Participants who are within 5 weeks of a 6 mg/kg dose or within 2 weeks of a 2 mg/kg dose of trastuzumab at the time of initial study dosing will not be required to have a re-loading dose but will begin treatment at 6 mg/kg.ARRY-380 will be escalated until MTD is defined or the maximum planned dose has been evaluated. The dose for subsequent dose levels will be determined according to the treatment-related AE observed during the cycle 1 (21 days) in the previous dose level
Group II: ARRY-380 Once DailyActive Control2 Interventions
ARRY-380 will be 750mg orally once-daily. Trastuzumab will be given at the standard full dose with a loading dose of 8 mg/kg on Day 1, cycle 1, followed by 6 mg/kg in subsequent cycles. Participants who are within 5 weeks of a 6 mg/kg dose or within 2 weeks of a 2 mg/kg dose of trastuzumab at the time of initial study dosing will not be required to have a re-loading dose but will begin treatment at 6 mg/kg. ARRY-380 will be escalated until MTD is defined or the maximum planned dose has been evaluated. The dose for subsequent dose levels will be determined according to the treatment-related AE observed during the cycle 1 (21 days) in the previous dose level

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,365 Total Patients Enrolled
141 Trials studying Breast Cancer
22,571 Patients Enrolled for Breast Cancer
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,394 Total Patients Enrolled
Breast Cancer Research FoundationOTHER
67 Previous Clinical Trials
137,556 Total Patients Enrolled
40 Trials studying Breast Cancer
130,307 Patients Enrolled for Breast Cancer

Media Library

ARRY-380 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01921335 — Phase 1
Breast Cancer Research Study Groups: ARRY-380 Twice Daily Dosage, ARRY-380 Once Daily
Breast Cancer Clinical Trial 2023: ARRY-380 Highlights & Side Effects. Trial Name: NCT01921335 — Phase 1
ARRY-380 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01921335 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the patient enrollment size of this trial?

"Unfortunately, this research is not currently recruiting. The trial was posted on the 1st of August 2013 and last updated on August 15th 2022. For those seeking to join other studies, there are 3101 trials for neoplasm metastasis and 199 clinical trials with ARRY-380 Twice Daily Dosage actively taking in patients."

Answered by AI

Has the FDA given authorization to use ARRY-380 at two intervals per day?

"The safety of ARRY-380 Twice Daily Dosage is assessed as a '1' on the 1 to 3 scale, due to it being in its first phase trialing and having limited data supporting both efficacy and security."

Answered by AI

What pathological conditions does ARRY-380 Twice Daily Dosage commonly address?

"ARRY-380 Twice Daily Dosage is generally administered to breast cancer patients, though its efficacy has also been observed when treating high risk of recurrence, first line treatment and surgery."

Answered by AI

Are new participants being admitted to this research endeavor?

"At the present moment, this medical study is not actively seeking patients. The trial was originally posted on August 1st 2013 and last updated on August 15th 2022. However, there are 3100 studies recruiting for neoplasm metastasis and 199 trials looking for ARRY-380 Twice Daily Dosage participants."

Answered by AI

Could you elaborate on other research which has explored the effectiveness of ARRY-380 Twice Daily Dosage?

"Currently, 199 clinical studies for the ARRY-380 Twice Daily Dosage are ongoing. Of those trials, 51 have reached Phase 3. Whilst many of these research projects are located in Phoenix, Arizona there exists 15774 sites offering this trial across the globe."

Answered by AI
~4 spots leftby Mar 2025