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Hormone Therapy
Trastuzumab Deruxtecan + Anastrozole for Breast Cancer
Phase 2
Recruiting
Led By Nicholas P McAndrew, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has adequate treatment washout period before randomization/enrollment, defined as: Major surgery >= 4 weeks, Chloroquine/hydroxychloroquine > 14 days
Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to surgery
Awards & highlights
Study Summary
This trial is investigating whether trastuzumab deruxtecan, either alone or in combination with anastrozole, is effective in treating patients with HER2 low, hormone receptor positive breast cancer.
Who is the study for?
This trial is for postmenopausal women or those willing to undergo ovarian suppression, with early-stage HER2 low, hormone receptor-positive breast cancer. They should have good physical function and no severe medical conditions that could interfere with the study. Participants must not have had certain prior treatments or conditions like active infections, recent heart issues, or a history of severe allergies to similar drugs.Check my eligibility
What is being tested?
The effectiveness of Trastuzumab Deruxtecan alone or combined with Anastrozole is being tested in patients with specific breast cancer types. Trastuzumab Deruxtecan targets and delivers chemotherapy directly to cancer cells while Anastrozole suppresses tumor growth by reducing estrogen production.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion-related responses, organ inflammation, blood disorders; digestive issues; fatigue; increased risk of infection; and possible heart problems due to the chemotherapy component.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had major surgery in the last 4 weeks or taken Chloroquine/hydroxychloroquine in the last 14 days.
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My tumor is hormone receptor positive for estrogen and progesterone.
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My tumor is low in HER2, confirmed by tests.
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My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last week.
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My white blood cell count is healthy without recent medication to increase it.
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My kidney function, measured by creatinine clearance, is adequate.
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My total bilirubin levels are within the normal range.
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My platelet count is at least 100,000 and I haven't had a transfusion in the last week.
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I am postmenopausal based on surgery, age, or hormone levels.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has not spread beyond nearby lymph nodes according to my latest scans.
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My breast cancer is larger than 2 cm and has not been treated yet.
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My breast cancer is operable, regardless of its spread to nearby lymph nodes.
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My estradiol levels are in the post-menopausal range.
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My heart is functioning well, with an ejection fraction of 50% or higher.
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I am pre- or peri-menopausal and have started ovarian suppression treatment at least 28 days ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ starting cycle 1 day 1 (each cycle is 21 days), through study completion, an average of 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~starting cycle 1 day 1 (each cycle is 21 days), through study completion, an average of 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response (pCR) rate
Secondary outcome measures
Biomarker analyses
Clinical objective response
Incidence of adverse events
+1 moreOther outcome measures
Quality of life assessment: questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (trastuzumab deruxtecan, anastrozole)Experimental Treatment3 Interventions
Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle and anastrozole PO QD on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Group II: Arm A (trastuzumab deruxtecan)Active Control2 Interventions
Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Anastrozole
2019
Completed Phase 4
~10300
Trastuzumab Deruxtecan
2021
Completed Phase 3
~510
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
25,962 Total Patients Enrolled
24 Trials studying Breast Cancer
1,758 Patients Enrolled for Breast Cancer
Translational Research in Oncology-U.SUNKNOWN
1 Previous Clinical Trials
74 Total Patients Enrolled
Daiichi Sankyo Co., Ltd.Industry Sponsor
115 Previous Clinical Trials
48,998 Total Patients Enrolled
4 Trials studying Breast Cancer
1,942 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment that goes through my whole body for cancer.In the past year, I've had a serious heart condition like a sudden stop in heartbeat or abnormal heart rhythm.I have had a stem-cell transplant.I haven't had major surgery in the last 4 weeks or taken Chloroquine/hydroxychloroquine in the last 14 days.I am not currently on ovarian hormonal replacement therapy.You have HIV, or active hepatitis B or C infection. If you have hepatitis C, you can still participate if a specific test shows that the virus is not currently active in your body.I had breast cancer in the other breast over 2 years ago, with no recurrence and no prior specific treatments.My tumor is hormone receptor positive for estrogen and progesterone.Your blood clotting times are within the normal range.Your doctor thinks you might not live for more than 3 months.My tumor is low in HER2, confirmed by tests.My hemoglobin level is at least 9.0 g/dL and I haven't had a blood transfusion in the last week.My white blood cell count is healthy without recent medication to increase it.I have inflammatory breast cancer.I have had other cancers, but they were either skin cancer removed by surgery, non-breast cancer that did not spread and was treated over 3 years ago with no return, or they were cured more than 3 years ago with no signs of coming back.My kidney function, measured by creatinine clearance, is adequate.My total bilirubin levels are within the normal range.I have or had lung inflammation that needed steroids, or it might be seen in my scans.I have severe lung problems or lung-related autoimmune diseases.Your liver enzyme levels (ALT and AST) should be within a certain range.My platelet count is at least 100,000 and I haven't had a transfusion in the last week.I have taken tamoxifen for DCIS but no other breast cancer treatments.I am postmenopausal based on surgery, age, or hormone levels.I am fully active or restricted in physically strenuous activity but can do light work.Your blood test shows that you have enough albumin in your body.I have had radiation therapy on the same side of my chest before.I have a blood clotting disorder and am on blood thinners.I had DCIS but haven't had hormone therapy or radiation on the same side.My cancer has not spread beyond nearby lymph nodes according to my latest scans.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.I cannot swallow pills.Women who could possibly have a baby need to have a negative pregnancy test.I have breast cancer in both breasts, with all tested areas being HER2 1+ or 2+, not FISH amplified, and hormone receptor positive.My breast cancer is larger than 2 cm and has not been treated yet.My breast cancer is operable, regardless of its spread to nearby lymph nodes.I haven't had a heart attack or severe heart failure in the last 6 months.I have not had major surgery in the last 4 weeks.Your heart's electrical activity takes longer than normal to complete a cycle, as measured by a special heart test.My estradiol levels are in the post-menopausal range.I am not on any cancer treatments except for drugs for ovarian function or bone health, which I started before joining.My heart is functioning well, with an ejection fraction of 50% or higher.I am pre- or peri-menopausal and have started ovarian suppression treatment at least 28 days ago.I don't have severe gut issues that affect how I absorb pills.My breast cancer has returned or spread to other parts.You have had serious allergic reactions to other monoclonal antibodies or to the drug's ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (trastuzumab deruxtecan)
- Group 2: Arm B (trastuzumab deruxtecan, anastrozole)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what maladies is Trastuzumab Deruxtecan regularly applied?
"Trastuzumab Deruxtecan is frequently prescribed to treat breast cancer. It can also be used in the management of malignant neoplasms, hormone receptor unknown cases and those with metastasized HER2-positive breast cancer who have undergone two or more anti-HER2 based treatments."
Answered by AI
What research has been done to investigate the efficacy of Trastuzumab Deruxtecan?
"In 2006, Trastuzumab Deruxtecan was initially trialled at Kaiser Permanente-Franklin. As of now, 146 studies have been concluded and 107 are still in progress; many of which take place within Fullerton, Massachusetts."
Answered by AI
How many health centers are currently conducting this experiment?
"At present, the medical trial has been established at 9 centres. These are situated in Fullerton, Los Alamitos and Boston to name a few. To lessen travelling commitments, it is suggested that participants pick the location closest to their abode."
Answered by AI
Has the FDA officially given their stamp of approval for Trastuzumab Deruxtecan?
"Trastuzumab Deruxtecan's safety is backed by some clinical data, thus it was assigned a score of 2 on our scale. Unfortunately, efficacy has not yet been established in this Phase 2 trial."
Answered by AI
Is this medical experiment actively looking for participants?
"According to the clinicaltrials.gov page, this research endeavour is actively recruiting participants. Its initial posting date was October 9th 2020 and it was last updated on September 19th 2022."
Answered by AI
What is the aggregate number of participants in this clinical investigation?
"To fulfill the requirements of this trial, 88 individuals that meet all inclusion criteria need to participate. These patients can register at St Joseph Heritage Healthcare located in Fullerton, Massachusetts or Cancer Blood and Specialty Clinic which is situated in Los Alamitos, Florida."
Answered by AI
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