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Monoclonal Antibodies

Dato-DXd + Durvalumab for Breast Cancer

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer

ECOG PS of 0 or 1

Must not have

Evidence of distant disease

Known HIV infection that is not well controlled

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the effectiveness and safety of new treatments for TNBC and hormone receptor-low/HER2-negative breast cancer.

Who is the study for?

Adults over 18 with Stage II or III breast cancer that's triple-negative or hormone receptor-low/HER2-negative can join. They need good bone marrow and organ function, an ECOG performance status of 0 or 1, a tumor sample for testing, and must follow local contraception rules.

What is being tested?

The study compares two treatments: Dato-DXd plus durvalumab (with/without chemo) versus pembrolizumab plus chemotherapy (with/without more chemo), both before and after surgery in patients who haven't had prior treatment for their breast cancer.

What are the potential side effects?

Possible side effects include immune-related reactions, fatigue, nausea, hair loss from chemotherapy drugs like Paclitaxel and Doxorubicin; heart issues from Epirubicin; blood cell count changes; potential kidney damage from Carboplatin.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is confirmed to be at Stage II or III and is either triple-negative or has low hormone receptors and is HER2-negative.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Exclusion Criteria

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

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My cancer has spread to parts of my body far from where it started.

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My HIV infection is not well controlled.

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I have an active tuberculosis infection.

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I have had lung inflammation not caused by an infection.

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I have a serious heart condition that is not under control.

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I have had treatment or surgery for triple-negative or low hormone receptor/HER2-negative breast cancer.

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

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I am currently pregnant, breastfeeding, or planning to become pregnant.

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I have a serious eye condition affecting my cornea.

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I do not have an infection needing IV drugs or have an undiagnosed infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of definitive surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of definitive surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of definitive surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event-free survival (EFS) in the experimental vs control arms

Pathologic Complete Response (pCR) in the experimental vs control arms

Secondary study objectives

Distant disease-free survival (DDFS) in the experimental vs control arms

Immunogenicity of Dato-DXd (in combination with durvalumab)

Overall Survival (OS) in the experimental vs control arms

+6 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd plus durvalumabExperimental Treatment9 Interventions

Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease Adjuvant chemotherapy may be one of these: 1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks); 2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks); 3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks); 4. Capecitabine (Q3W) for 8 cycles.

Group II: Pembrolizumab plus chemotherapyActive Control8 Interventions

Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epirubicin

2012

Completed Phase 4

~19470

Durvalumab

2017

Completed Phase 2

~3750