What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly antibody-drug conjugates like Datopotamab Deruxtecan, often have side effects such as neutropenia, anemia, nausea, and fatigue. Trastuzumab deruxtecan, for example, is associated with interstitial lung disease, decreased neutrophil count, and anemia. Standard chemotherapies like eribulin, capecitabine, vinorelbine, and gemcitabine can cause side effects including myelosuppression, neuropathy, gastrointestinal disturbances, and alopecia. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several Antibody-Drug Conjugates (ADCs) have been approved by the FDA for the treatment of breast cancer. Notably, Trastuzumab emtansine (T-DM1) and Fam-trastuzumab deruxtecan (T-DXd) are approved for HER2-positive breast cancer. T-DM1 combines trastuzumab with the cytotoxic agent emtansine, while T-DXd links trastuzumab to deruxtecan. These treatments are designed to deliver cytotoxic drugs directly to cancer cells expressing the HER2 receptor, thereby minimizing systemic exposure and enhancing efficacy. While Datopotamab Deruxtecan targets Trop-2, these ADCs targeting HER2 provide a similar mechanism of action by combining targeted therapy with chemotherapy.

What other types of research exist?

Promising novel alternatives to Datopotamab Deruxtecan for breast cancer patients include: 1) Sacituzumab Govitecan (an antibody-drug conjugate targeting Trop-2), 2) Trastuzumab Deruxtecan (an antibody-drug conjugate targeting HER2), and 3) Tucatinib (a HER2-targeted tyrosine kinase inhibitor). These therapies have shown efficacy in clinical trials and are considered advanced options for breast cancer treatment.

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Antibody-Drug Conjugate

Dato-DXd for Breast Cancer (TB-01 Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ and bone marrow function within 7 days before day of first dosing as follows: Hemoglobin: ≥ 9.0 g/L, Absolute neutrophil count: 1500/mm3, Platelet count: 100000/mm3, Total bilirubin: ≤ 1.5 × ULN if no liver metastases; or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline, ALT and AST: ≤ 3 × ULN for AST/ALT; however, if elevation is due to liver metastases, ≤ 5.0 × ULN is allowed, Calculated creatinine clearance: ≥ 30 mL/min as calculated using the Cockcroft-Gault equation (using actual body weight), LVEF ≥ 50% by either an echocardiogram or MUGA within 28 days of first dosing

At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1. Note: Participants with bone-only metastases are not permitted

Must not have

Known active or uncontrolled hepatitis B or C infection; or positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (HBsAg, anti-HBs, anti-HBc, or HBV DNA) or hepatitis C (HCV antibody or HCV RNA) infection at screening

Mean resting corrected QTcF interval > 470 ms , obtained from triplicate ECGs performed at screening, History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes, Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening, Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy, Leptomeningeal carcinomatosis, Clinically significant corneal disease, Known active tuberculosis infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to event up to 21 months; from date of first response until progression or death up to 20 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug called datopotamab deruxtecan to see if it helps patients with advanced breast cancer live longer or have a better quality of life compared to standard chemotherapy. Datopotamab deruxtecan has shown encouraging response rates and manageable toxicity in patients with advanced/metastatic triple-negative breast cancer.

Who is the study for?

Adults with inoperable or metastatic HR-positive, HER2-negative breast cancer who have tried 1-2 chemotherapy lines and aren't suitable for endocrine therapy. They must be well enough (ECOG PS of 0 or 1), have adequate organ function, no severe heart conditions, controlled blood pressure, and not pregnant. Participants need a measurable lesion that's RECIST 1.1 compliant and can't have active brain metastases requiring steroids.

What is being tested?

The trial is testing Dato-DXd against standard single-agent chemotherapies like eribulin, capecitabine, vinorelbine, or gemcitabine in patients with certain advanced breast cancers. It aims to see if Dato-DXd is safer or more effective compared to these existing treatments.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk; potential liver enzyme changes; hair loss may occur due to chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, liver, kidney, and heart functions meet the trial's requirements.

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I have a tumor that can be measured and hasn't been treated with radiation.

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I've had 1-2 chemotherapy treatments for my inoperable/metastatic cancer and it's still progressing.

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My breast cancer cannot be removed by surgery and is HR+ and HER2-.

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I am 18 years old or older.

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I am 18 years old or older.

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I am using birth control approved by this study's guidelines, not including oral estrogens.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active or uncontrolled hepatitis B or C.

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Criterion: You have a history of heart rhythm problems, lung inflammation, lung problems, severe lung diseases, brain and spinal cord cancer spread, serious eye problems, or active tuberculosis.

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I do not have an ongoing infection needing IV treatment.

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My HIV infection is not well controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to event up to 21 months; from date of first response until progression or death up to 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to event up to 21 months; from date of first response until progression or death up to 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to event up to 21 months; from date of first response until progression or death up to 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Progression Free Survival

Secondary study objectives

Clinical Outcome Assessment- TTD in GHS

Clinical Outcome Assessment- TTD in pain

Clinical Outcome Assessment- TTD in physical Functioning

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXdExperimental Treatment1 Intervention

Arm 1: Dato-DXd

Group II: Investigators Choice of Chemotherapy (ICC)Active Control4 Interventions

Arm 2: ICC Capecitabine Gemcitabine Eribulin mesylate Vinorelbine

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-Drug Conjugates (ADCs) such as Datopotamab Deruxtecan work by combining a monoclonal antibody specific to a cancer cell antigen (like Trop-2) with a potent cytotoxic drug. The antibody targets and binds to the cancer cells, delivering the cytotoxic drug directly to the tumor, which helps to kill the cancer cells while sparing healthy tissue. This targeted approach is significant for breast cancer patients as it aims to reduce side effects and improve the efficacy of treatment. Other common treatments for breast cancer include hormone therapy, chemotherapy, and targeted therapy, each working through different mechanisms such as blocking hormone receptors, killing rapidly dividing cells, or inhibiting specific cancer cell proteins.

Safety of trastuzumab deruxtecan: A meta-analysis and pharmacovigilance study.Aiming at a Tailored Cure for ERBB2-Positive Metastatic Breast Cancer: A Review.Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study.