50 Participants Needed

Trastuzumab Deruxtecan for Breast Cancer

SL
JH
Overseen ByJulie Holub, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) before starting the study drug. This means you may need to stop taking some of your current medications for a certain period before joining the trial. It's best to discuss your specific medications with the study team to understand what changes might be needed.

What data supports the effectiveness of the drug Trastuzumab Deruxtecan for breast cancer?

Trastuzumab Deruxtecan has shown effectiveness in treating HER2-positive breast cancer, especially in patients who have already tried other treatments. In studies, it helped patients live longer without the cancer getting worse compared to previous treatments, and it was generally safe to use with manageable side effects.12345

Is Trastuzumab Deruxtecan safe for humans?

Trastuzumab Deruxtecan has a generally manageable safety profile, but it can cause some side effects like nausea, vomiting, and blood and stomach issues. Serious concerns include lung problems (interstitial lung disease) and heart issues, which require careful monitoring.25678

How is the drug Trastuzumab Deruxtecan unique for treating HER2-positive breast cancer?

Trastuzumab Deruxtecan is unique because it is an antibody-drug conjugate that combines a targeted anti-HER2 antibody with a powerful chemotherapy agent, allowing it to deliver the drug directly to cancer cells. This approach can be more effective and have a longer response duration compared to previous treatments like trastuzumab emtansine, especially in patients who have already received other anti-HER2 therapies.12359

What is the purpose of this trial?

The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.

Research Team

ML

Maryam Lustberg, M.D.

Principal Investigator

Yale University

Eligibility Criteria

Adults with metastatic HER2-negative breast cancer, either hormone receptor-positive or negative, who have had 1-2 prior systemic treatments but no anti-HER2 therapy. Participants must have measurable disease and good heart, bone marrow, kidney, liver, and blood clotting function. They should not be pregnant or breastfeeding and must use contraception.

Inclusion Criteria

I can understand and sign the consent form.
Pathologically documented breast cancer that is unresectable or metastatic, has always been HER2-IHC 0 and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior pathology testing according to ASCO-CAP guidelines, is either HR-positive or HR-negative per ASCO-CAP guidelines, has or has not been treated with a CDK4/6 inhibitor, has been treated with 1 or 2 prior lines of systemic therapy in the metastatic setting, was never previously treated with anti-HER2 therapy, documented radiologic progression during or after most recent treatment, adequate archival tumor sample <3 years-old available for assessment of HER2 status, presence of at least 1 measurable lesion based on CT or MRI per mRECIST version 1.1, ECOG PS 0 or 1, LVEF ≥50% within 28 days prior to C1D1, adequate bone marrow function, renal function, hepatic function, blood clotting function, treatment washout period, evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential, and appropriate contraceptive measures for sexually active patients

Exclusion Criteria

Uncontrolled or significant cardiovascular disease including recent myocardial infarction or symptomatic congestive heart failure, history of ILD/pneumonitis, spinal cord compression or active CNS metastases, multiple primary malignancies within 3 years, severe hypersensitivity reactions, uncontrolled infections, substance abuse or medical conditions that may increase safety risk, social, familial, or geographical factors interfering with study participation, HIV infection or active hepatitis B or C infection, unresolved toxicities from previous anticancer therapy, recent therapeutic radiation therapy or major surgery, recent systemic treatment with anticancer therapy, current treatment with specific inhibitors, recent participation in other clinical studies, pregnancy, breastfeeding, or planning pregnancy, study site personnel or immediate family members, recent live attenuated vaccine receipt, lung-specific intercurrent illnesses, autoimmune disorders with pulmonary involvement, prior pneumonectomy, and other reasons deemed inappropriate by the Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trastuzumab Deruxtecan intravenously every 3 weeks at a dose of 5.4 mg/kg until disease progression, limiting toxicity, withdrawal of consent, or death

21 days per cycle, indefinite number of cycles
1 visit every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 days
1 visit (in-person)

Long-term follow-up

Overall survival and progression-free survival are monitored every 3 months

Up to 3 years
1 visit every 3 months (in-person)

Treatment Details

Interventions

  • Trastuzumab Deruxtecan
Trial Overview The trial is evaluating the effects of Trastuzumab Deruxtecan (T-DXd) on patients with advanced breast cancer that lacks a protein called HER2. The study aims to determine both positive outcomes and potential adverse reactions to T-DXd in this specific patient group.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Trastuzumab DeruxtecanExperimental Treatment1 Intervention
T-DXd will be administered intravenously every 3 weeks at a dose of 5.4 mg per kilogram of body weight until disease progression, limiting toxicity, withdrawal of consent, or death. For T-DXd, each cycle of treatment will be 21 days. The number of treatment cycles with T-DXd is not fixed.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Findings from Research

In the TUXEDO-1 trial involving 15 patients with HER2-positive breast cancer and brain metastases, trastuzumab deruxtecan achieved a high overall intracranial response rate of 73.3%, indicating its efficacy in treating this challenging condition.
The treatment was well-tolerated, with no new safety concerns reported, and patients maintained their quality of life and cognitive functioning throughout the study.
Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial.Bartsch, R., Berghoff, AS., Furtner, J., et al.[2022]
Trastuzumab deruxtecan (Enhertu®) has been shown to significantly improve progression-free survival in adults with unresectable or metastatic HER2-positive breast cancer compared to the previous standard treatment, trastuzumab emtansine, in a pivotal phase 3 trial.
The treatment has a generally manageable safety profile, although it is associated with common adverse events like hematological and gastrointestinal disorders, and requires careful monitoring for interstitial lung disease (ILD)/pneumonitis.
Trastuzumab Deruxtecan: A Review in Unresectable or Metastatic HER2-Positive Breast Cancer.Nie, T., Blair, HA.[2023]
In a phase 2 study involving 184 patients with HER2-positive metastatic breast cancer who had previously been treated with trastuzumab emtansine, trastuzumab deruxtecan demonstrated a significant response rate of 60.9%, with a median response duration of 14.8 months.
While trastuzumab deruxtecan showed promising efficacy, it was associated with notable adverse effects, including interstitial lung disease in 13.6% of patients, highlighting the need for careful monitoring of pulmonary symptoms during treatment.
Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer.Modi, S., Saura, C., Yamashita, T., et al.[2021]

References

Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. [2022]
Trastuzumab Deruxtecan: A Review in Unresectable or Metastatic HER2-Positive Breast Cancer. [2023]
Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. [2021]
Trastuzumab deruxtecan versus treatment of physician's choice in patients with HER2-positive metastatic breast cancer (DESTINY-Breast02): a randomised, open-label, multicentre, phase 3 trial. [2023]
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. [2020]
Management of Chemotherapy-Induced Nausea and Vomiting with Trastuzumab Deruxtecan: A Case Series. [2022]
Safety of trastuzumab deruxtecan: A meta-analysis and pharmacovigilance study. [2023]
Incidence of interstitial lung disease and cardiotoxicity with trastuzumab deruxtecan in breast cancer patients: a systematic review and single-arm meta-analysis. [2023]
Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study. [2020]
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