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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

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

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

100%

80%

60%

40%

20%

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.

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

0 / 11Eligibility criteria met