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Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer

NCT03894007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-09-23

No results posted yet for this study

Summary

This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.

Conditions

Interventions

DRUG

Docetaxel

75 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 4 courses preoperatively.

DRUG

Carboplatin

AUC 6 iv, day 1 every third week, 4 courses preoperatively.

DRUG

Trastuzumab

600 mg sc, day 1 every third week, 4 courses preoperatively. 14 courses postoperatively if complete response.

DRUG

Pertuzumab

840 mg iv starting dose, thereafter 420 mg, day 1 every third week. 14 courses postoperatively if complete response in patients with baseline high risk tumours.

DRUG

Epirubicin

90 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 3 courses preoperatively

DRUG

Cyclophosphamide

600 mg/m2 iv, day 1 every third week, 3 courses preoperatively

DRUG

Atezolizumab

840 mg iv, day 1 every third week, 3 courses preoperatively if randomised to arm A.

DRUG

Trastuzumab emtansine

3.6 mg/kg iv, day 1 every third week, 14 courses postoperatively if not complete response.

DRUG

Paclitaxel

80 mg/m2 iv, day 1 weekly, 12 weeks (4 cycles), in case of (anticipated) unmanageable toxicity related to docetaxel.

Sponsors & Collaborators

  • Renske Altena

    lead OTHER

Principal Investigators

  • Renske Altena, MD, PhD · Karolinska University Hospital

  • Jonas Bergh, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Drug
Yes

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894007 on ClinicalTrials.gov