What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving antibody-drug conjugates like Sacituzumab Govitecan-hziy and trastuzumab, often present a range of side effects. Trastuzumab, for instance, is associated with adverse events such as diarrhea, rash, hepatic issues, and ocular side effects like dry eyes and conjunctivitis. Severe but rare ocular conditions include macular edema and retinal detachment. General chemotherapy side effects, which may accompany these targeted therapies, include nausea, fatigue, and increased risk of infection. These side effects vary in severity and frequency, necessitating close monitoring and supportive care during treatment.

What prior FDA approvals exist?

The FDA has approved several antibody-drug conjugates (ADCs) for the treatment of breast cancer, similar to Sacituzumab Govitecan-hziy. Notably, Trastuzumab emtansine (T-DM1) is an ADC targeting HER2-positive breast cancer, combining the HER2-targeted action of trastuzumab with the cytotoxic agent DM1. Another significant ADC is Trastuzumab deruxtecan, also targeting HER2-positive breast cancer, which links trastuzumab to a topoisomerase inhibitor. These treatments exemplify the targeted approach of ADCs in delivering cytotoxic drugs directly to cancer cells, thereby minimizing systemic toxicity.

What other types of research exist?

Promising novel alternatives to Sacituzumab Govitecan-hziy for breast cancer patients include: <ol> <li>Trastuzumab Deruxtecan (Enhertu) - An antibody-drug conjugate targeting HER2, showing efficacy in HER2-positive breast cancer.</li> <li></li> </ol> Pembrolizumab (Keytruda) - An immunotherapy targeting PD-1, used in combination with chemotherapy for triple-negative breast cancer. 3. Tucatinib (Tukysa) - A HER2-targeted tyrosine kinase inhibitor, often used in combination with trastuzumab and capecitabine for HER2-positive metastatic breast cancer. 4. Alpelisib (Piqray) - A PI3K inhibitor used in combination with fulvestrant for HR-positive, HER2-negative advanced breast cancer with PIK3CA mutations.

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Monoclonal Antibodies

Sacituzumab Govitecan for Triple-Negative Breast Cancer (ASCENT-03 Trial)

Phase 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Individuals presenting with de novo metastatic TNBC

Individuals with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)

Must not have

Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease

Active second malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to approximately 57 months

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a drug called sacituzumab govitecan-hziy, which targets and kills cancer cells. It focuses on patients with advanced triple-negative breast cancer who have limited treatment options. The drug works by attaching to cancer cells and releasing a substance that kills them. Sacituzumab govitecan-hziy is an FDA-approved treatment for metastatic triple-negative breast cancer, especially for patients who have already tried other treatments.

Who is the study for?

This trial is for adults with previously untreated advanced or metastatic triple-negative breast cancer that doesn't show PD-L1, or those who've had anti-PD-(L)1 treatment if their tumors are PD-L1 positive. Participants must have good organ function, not be pregnant, and agree to use contraception. They can't join if they've had recent cancer treatments, active infections requiring antibiotics, another active cancer, or haven’t recovered from past treatment side effects.

What is being tested?

The study compares Sacituzumab Govitecan-hziy (SG), a new drug for breast cancer, against the physician's choice of standard treatments like Paclitaxel or nab-Paclitaxel combined with Gemcitabine and Carboplatin. The main goal is to see which option keeps the cancer from worsening longer (progression-free survival).

What are the potential side effects?

Sacituzumab Govitecan-hziy may cause nausea, diarrhea, hair loss, fatigue and low blood cell counts leading to increased infection risk. Standard chemotherapy drugs can also cause similar side effects including allergic reactions and potential damage to nerves resulting in numbness.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer was already at an advanced stage when first diagnosed.

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I have triple-negative breast cancer that has not been treated and cannot be removed by surgery.

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My cancer can be measured by scans according to specific criteria.

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My triple-negative breast cancer and PD-L1 status are confirmed.

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

Exclusion Criteria

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

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I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.

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I have another type of cancer that is currently active.

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I have been treated with drugs targeting DNA replication before.

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I have an active hepatitis B or C infection.

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I am still experiencing side effects from a previous treatment.

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I haven't had cancer treatment or radiation in the last 6 months and 2 weeks, respectively.

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I am currently taking antibiotics for a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to approximately 57 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization up to approximately 57 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 57 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

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary study objectives

Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).

Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1

Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

+3 more

Side effects data

From 2023 Phase 3 trial • 543 Patients • NCT03901339

54%

Neutropenia

35%

Nausea

33%

Fatigue

27%

Anaemia

24%

Constipation

23%

Diarrhoea

21%

Decreased appetite

20%

Asthenia

18%

Aspartate aminotransferase increased

18%

Pyrexia

18%

Alopecia

16%

Vomiting

16%

Thrombocytopenia

15%

Dyspnoea

15%

Alanine aminotransferase increased

14%

Abdominal pain

14%

Headache

12%

Arthralgia

12%

Back pain

12%

Lymphopenia

11%

Blood alkaline phosphatase increased

10%

Urinary tract infection

10%

Leukopenia

Insomnia

Myalgia

Neuropathy peripheral

Hyperglycaemia

Cough

Stomatitis

Blood bilirubin increased

Weight decreased

Peripheral sensory neuropathy

Rash

Abdominal pain upper

Palmar-plantar erythrodysaesthesia syndrome

Oedema peripheral

Bone pain

Paraesthesia

Mucosal inflammation

Blood lactate dehydrogenase increased

Pain in extremity

Muscle spasms

Hypokalaemia

Gastrooesophageal reflux disease

Pain

Febrile neutropenia

Hypertension

Hypomagnesaemia

Dizziness

Dry skin

Abdominal distension

Dyspepsia

Dry mouth

Pneumonia

Pruritus

Epistaxis

Confusional state

Dehydration

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Sacituzumab Govitecan-hziy (SG)Experimental Treatment1 Intervention

Participants will receive SG 10 mg/kg on Days 1 and 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 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab govitecan

FDA approved

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-drug conjugates (ADCs) like Sacituzumab Govitecan-hziy represent a significant advancement in breast cancer treatment. These therapies combine monoclonal antibodies that specifically target cancer cell markers, such as Trop-2, with potent cytotoxic drugs. By delivering the cytotoxic agent directly to the cancer cells, ADCs minimize damage to healthy tissues, enhancing treatment efficacy and reducing side effects. This targeted approach is particularly important for breast cancer patients, as it offers a more effective and less toxic treatment option, potentially improving survival rates and quality of life.

SABCS 2020: update on triple-negative and metastatic HER2-positive breast cancer.Antibody-drug conjugates as novel anti-cancer chemotherapeutics.Trastuzumab in the Treatment of Breast Cancer.