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Trastuzumab Deruxtecan + Anastrozole for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm A (trastuzumab deruxtecan)
- Group 2: Arm B (trastuzumab deruxtecan, anastrozole)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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