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Antibody Drug Conjugate

Sacituzumab Govitecan for Breast Cancer (SERIES Trial)

Phase 2
Recruiting
Led By Reshma L Mahtani, D.O.
Research Sponsored by Reshma L. Mahtani, D.O.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Prior treatment with T-DXd discontinued for progression and/or intolerance
Must not have
Locally advanced MBC in individuals who are candidates for curative intent therapy
Patients with brain metastases except for asymptomatic treated BM not requiring ongoing corticosteroid treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Summary

This trial aims to determine if the medication sacituzumab govitecan (SG) is effective in people with metastatic, hormone receptor positive (HR+)/human epidermal growth factor

Who is the study for?
This trial is for individuals with metastatic, hormone receptor positive (HR+)/HER2 low breast cancer who have previously been treated with trastuzumab deruxtecan. Participants must meet specific health criteria to join.Check my eligibility
What is being tested?
The study tests the effectiveness of sacituzumab govitecan (SG) at its approved dose and schedule in patients who've already received T-DXd for their HR+/HER2 low metastatic breast cancer.See study design
What are the potential side effects?
Sacituzumab govitecan may cause side effects such as nausea, diarrhea, hair loss, fatigue, neutropenia (low white blood cell count), and anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I stopped T-DXd treatment due to worsening or side effects.
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My breast cancer is advanced, cannot be surgically removed, and is hormone receptor positive.
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I have been treated with a CDK4/6 inhibitor, with or without hormone therapy.
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My organs and bone marrow are working well.
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My cancer has worsened after my last treatment.
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My breast cancer is advanced, cannot be surgically removed, and is HER2-low but hormone receptor positive.
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I've had 1 to 4 chemotherapy treatments for my cancer after it spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is advanced but can still be treated with the goal of curing it.
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I have brain metastases but don't need ongoing steroids.
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I am currently on antibiotics for a serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Global Quality of Life
+5 more

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455
40%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan (SG) InfusionExperimental Treatment1 Intervention
SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
2017
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,086 Previous Clinical Trials
848,355 Total Patients Enrolled
16 Trials studying Breast Cancer
6,379 Patients Enrolled for Breast Cancer
Reshma L. Mahtani, D.O.Lead Sponsor
Reshma L Mahtani, D.O.Principal InvestigatorMiami Cancer Institute at Baptist Health, Inc.
~50 spots leftby Jun 2026