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Hormone Therapy

Trastuzumab Deruxtecan + Anastrozole for Breast Cancer

Phase 2

Recruiting

Led By Nicholas P McAndrew, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Has adequate treatment washout period before randomization/enrollment, defined as: Major surgery >= 4 weeks, Chloroquine/hydroxychloroquine > 14 days

Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined

Must not have

Inflammatory breast cancer

Prior systemic therapy for invasive cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to surgery

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for postmenopausal women or those willing to undergo ovarian suppression, with early-stage HER2 low, hormone receptor-positive breast cancer. They should have good physical function and no severe medical conditions that could interfere with the study. Participants must not have had certain prior treatments or conditions like active infections, recent heart issues, or a history of severe allergies to similar drugs.

What is being tested?

The effectiveness of Trastuzumab Deruxtecan alone or combined with Anastrozole is being tested in patients with specific breast cancer types. Trastuzumab Deruxtecan targets and delivers chemotherapy directly to cancer cells while Anastrozole suppresses tumor growth by reducing estrogen production.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as infusion-related responses, organ inflammation, blood disorders; digestive issues; fatigue; increased risk of infection; and possible heart problems due to the chemotherapy component.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had major surgery in the last 4 weeks or taken Chloroquine/hydroxychloroquine in the last 14 days.

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My tumor is hormone receptor positive for estrogen and progesterone.

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My white blood cell count is healthy without recent medication to increase it.

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

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My cancer has not spread beyond nearby lymph nodes according to my latest scans.

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My breast cancer is larger than 2 cm and has not been treated yet.

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My estradiol levels are in the post-menopausal range.

Exclusion Criteria

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

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I have inflammatory breast cancer.

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I have had treatment that goes through my whole body for cancer.

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I have had a stem-cell transplant.

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I have severe lung problems or lung-related autoimmune diseases.

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I have taken tamoxifen for DCIS but no other breast cancer treatments.

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I have had radiation therapy on the same side of my chest before.

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I have a blood clotting disorder and am on blood thinners.

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I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.

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I cannot swallow pills.

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I haven't had a heart attack or severe heart failure in the last 6 months.

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I don't have severe gut issues that affect how I absorb pills.

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My breast cancer has returned or spread to other parts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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

Pathologic complete response (pCR) rate

Secondary study objectives

Biomarker analyses

Clinical objective response

Incidence of adverse events

+1 more

Other study objectives

Quality of life assessment: questionnaire

Side effects data

From 2024 Phase 2 trial • 95 Patients • NCT04989816

77%

Anaemia

73%

White blood cell count decreased

61%

Neutrophil count decreased

53%

Platelet count decreased

43%

Nausea

40%

Decreased appetite

39%

Hypoalbuminaemia

32%

Aspartate aminotransferase increased

32%

Vomiting

28%

Weight decreased

26%

Hypokalaemia

25%

Asthenia

25%

Alanine aminotransferase increased

24%

Hypocalcaemia

22%

Hyponatraemia

19%

Constipation

19%

Fatigue

17%

Lymphocyte count decreased

15%

Diarrhoea

13%

Covid-19

12%

Blood alkaline phosphatase increased

12%

Gamma-glutamyltransferase increased

12%

Blood bilirubin increased

Hyperuricaemia

Pyrexia

Dizziness

Hyperglycaemia

Abdominal distension

Oedema peripheral

Insomnia

Thrombocytopenia

Bilirubin conjugated increased

Blood creatinine increased

White blood cell count increased

Hypochloraemia

Abdominal pain

Dyspepsia

Hypoaesthesia

Coronavirus infection

Cough

Pneumonia

Hepatic function abnormal

Amylase increased

Blood lactate dehydrogenase increased

Ejection fraction decreased

Hypoproteinaemia

Back pain

Mouth ulceration

Interstitial lung disease

Productive cough

Covid-19 pneumonia

Gastrointestinal haemorrhage

Febrile neutropenia

Death

Cerebral infarction

Myelosuppression

Haemorrhage intracranial

Dysphagia

Jaundice cholestatic

Gastrointestinal infection

Malnutrition

Mental disorder

Haematuria

Renal failure

Pulmonary embolism

Deep vein thrombosis

Arrhythmia

Sepsis

Upper gastrointestinal haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

T-DXd

Awards & Highlights

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: Arm B (trastuzumab deruxtecan, anastrozole)Experimental Treatment3 Interventions

Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle and anastrozole PO QD on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Group II: Arm A (trastuzumab deruxtecan)Active Control2 Interventions

Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2016

Completed Phase 4

~5550

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630