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RecruitingLast updated: 19 April 2024

TROPION-Breast04: This clinical trial is evaluating different combinations of therapies (including an anti-body drug conjugate, immunotherapy and chemotherapy) for the treatment of adults with previously untreated, triple-negative or hormone receptor-low/HER2-negative breast cancerA Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive a regimen containing the antibody-drug conjugate called Datopotamab Deruxtecan (Dato-DXd) plus durvalumab immunotherapy, with or without chemotherapy.

Participants receive durvalumab (via IV infusion) + Dato-DXd (via IV infusion) every 3 weeks (Q3W) as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvalumab (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:

  • 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);
  • Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks);
  • Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks);
  • Capecitabine (Q3W) for 8 cycles. 

In the Active Comparator Arm, participants will receive pembrolizumab immunotherapy plus chemotherapy.

Participants will receive pembrolizumab (via IV Infusion) Q3W + paclitaxel (weekly) + carboplatin (weekly or Q3W) for 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W for 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. 

Conditions

This trial is treating patients with triple negative breast cancer or hormone receptor-low/HER2-negative breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

TROPION-Breast04

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • D926QC00001

Trial sponsor

AstraZeneca

Scientific Title

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Eligibility

Inclusion

  • Participant must be ≥ 18 years, at the time of signing the ICF.
  • 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
  • Provision of acceptable tumor sample
  • Adequate bone marrow reserve and organ function
  • Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
  • Evidence of distant disease.
  • Clinically significant corneal disease.
  • Has active or uncontrolled hepatitis B or C virus infection.
  • Known HIV infection that is not well controlled.
  • Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
  • Known to have active tuberculosis infection
  • Resting ECG with clinically significant abnormal findings.
  • Uncontrolled or significant cardiac disease.
  • History of non-infectious ILD/pneumonitis
  • Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
  • For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
  • Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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