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Monoclonal Antibodies
Sacituzumab Govitecan-hziy for Breast Cancer (TROPiCS-02 Trial)
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 43.4 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new medication called sacituzumab govitecan-hzi for patients with a specific type of advanced breast cancer. Sacituzumab govitecan is a new type of medication that has been approved for treating a specific kind of advanced breast cancer. The medication targets and kills cancer cells by delivering a toxic substance directly to them. The goal is to see if it works better and is safer than other treatments chosen by doctors.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 43.4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 43.4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment
Secondary study objectives
Clinical Benefit Rate (CBR) by BICR and LIR Assessment
Duration of Response (DOR) by BICR and LIR Assessment
Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment
+9 moreSide effects data
From 2023 Phase 3 trial • 543 Patients • NCT0390133954%
Neutropenia
35%
Nausea
33%
Fatigue
27%
Anaemia
24%
Constipation
23%
Diarrhoea
21%
Decreased appetite
20%
Asthenia
18%
Pyrexia
18%
Alopecia
18%
Aspartate aminotransferase increased
16%
Thrombocytopenia
16%
Vomiting
15%
Dyspnoea
15%
Alanine aminotransferase increased
14%
Abdominal pain
14%
Headache
12%
Back pain
12%
Arthralgia
12%
Lymphopenia
11%
Blood alkaline phosphatase increased
10%
Urinary tract infection
10%
Leukopenia
8%
Insomnia
8%
Myalgia
8%
Neuropathy peripheral
7%
Hyperglycaemia
7%
Cough
7%
Stomatitis
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Weight decreased
6%
Peripheral sensory neuropathy
6%
Rash
6%
Blood bilirubin increased
6%
Abdominal pain upper
6%
Oedema peripheral
6%
Bone pain
6%
Paraesthesia
6%
Mucosal inflammation
5%
Pain in extremity
5%
Blood lactate dehydrogenase increased
4%
Muscle spasms
4%
Hypokalaemia
4%
Gastrooesophageal reflux disease
4%
Pain
4%
Hypertension
4%
Febrile neutropenia
4%
Hypomagnesaemia
4%
Dizziness
3%
Dry skin
3%
Dyspepsia
3%
Abdominal distension
2%
Dry mouth
2%
Pneumonia
2%
Pruritus
2%
Epistaxis
1%
Confusional state
1%
Dehydration
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
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: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention
Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.
Group II: Treatment of Physician's Choice (TPC)Active Control4 Interventions
Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:
Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)
* Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
* Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
* Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
* Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2021
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,135 Previous Clinical Trials
867,493 Total Patients Enrolled
18 Trials studying Breast Cancer
6,247 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
360 Previous Clinical Trials
191,944 Total Patients Enrolled
3 Trials studying Breast Cancer
815 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received previous treatment with certain medications called topoisomerase 1 inhibitors.You have received at least one type of taxane medication in the past.You can receive one of the chemotherapy treatments mentioned in the TPC arm.Your disease has gotten worse after your last treatment.You currently have a severe infection that requires treatment with antibiotics.You have received hormonal treatment for cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of Physician's Choice (TPC)
- Group 2: Sacituzumab Govitecan-hziy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.