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Monoclonal Antibodies
Sacituzumab Govitecan for Breast Cancer (ASCENT-07 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 approximately 60 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare a new drug (SG) to current treatments for metastatic breast cancer to see if it can improve life spans. Primary objective is to compare its effect on progression-free survival (PFS).
Who is the study for?
This trial is for adults with HR+/HER2- metastatic breast cancer who've had disease progression despite endocrine therapy. They must have a sample of tumor tissue available, not be candidates for further endocrine treatment, and have adequate organ function. HIV-positive participants need controlled infection on ART. Participants must agree to use contraception and should not be eligible for curative intent therapy or have received certain prior treatments.
What is being tested?
The study tests if Sacituzumab Govitecan (SG) extends the time without cancer growth in patients with HR+/HER2- metastatic breast cancer compared to standard treatments like Paclitaxel, Nab-paclitaxel, or Capecitabine. It measures how long patients live without their disease getting worse.
What are the potential side effects?
Sacituzumab Govitecan can cause side effects such as nausea, diarrhea, hair loss, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Standard chemotherapy drugs may also cause similar side effects including allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 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) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Secondary study objectives
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
+4 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%
Aspartate aminotransferase increased
18%
Alopecia
18%
Pyrexia
16%
Thrombocytopenia
16%
Vomiting
15%
Alanine aminotransferase increased
15%
Dyspnoea
14%
Abdominal pain
14%
Headache
12%
Lymphopenia
12%
Arthralgia
12%
Back pain
11%
Blood alkaline phosphatase increased
10%
Leukopenia
10%
Urinary tract infection
8%
Insomnia
8%
Neuropathy peripheral
8%
Myalgia
7%
Cough
7%
Stomatitis
7%
Hyperglycaemia
6%
Blood bilirubin increased
6%
Abdominal pain upper
6%
Weight decreased
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Peripheral sensory neuropathy
6%
Rash
6%
Oedema peripheral
6%
Mucosal inflammation
6%
Bone pain
6%
Paraesthesia
5%
Blood lactate dehydrogenase increased
5%
Pain in extremity
4%
Muscle spasms
4%
Hypokalaemia
4%
Gastrooesophageal reflux disease
4%
Pain
4%
Febrile neutropenia
4%
Hypomagnesaemia
4%
Dizziness
4%
Hypertension
3%
Abdominal distension
3%
Dyspepsia
3%
Dry skin
2%
Pneumonia
2%
Dry mouth
2%
Pruritus
2%
Epistaxis
1%
Confusional state
1%
Pleural effusion
1%
Dehydration
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-hziy (SG)Experimental Treatment1 Intervention
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Group II: Treatment of Physician's Choice (TPC)Active Control3 Interventions
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens:
* paclitaxel 80 mg/m\^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
* nab-Paclitaxel 100 mg/m\^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
* capecitabine at 1000-1250 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
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
1,129 Previous Clinical Trials
866,453 Total Patients Enrolled
16 Trials studying Breast Cancer
6,177 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
191,462 Total Patients Enrolled
2 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is hormone receptor positive and has spread, confirmed by a recent biopsy.I haven't taken any experimental estrogen-blocking drugs in the last 14 days.I am HIV positive with a history of Kaposi sarcoma or Multicentric Castleman Disease.My organs are functioning well.My cancer returned within 24 months while on hormone therapy, counting as one treatment line.My breast cancer is advanced but considered treatable with the intent to cure.I agree to use birth control as required by the study.I have received treatment targeting topoisomerase I.I have previously been treated with a Trop-2-targeting therapy.My cancer worsened within 6 months after finishing early-stage chemotherapy.I have active hepatitis B or C.My cancer worsened within 6 months after starting hormone therapy for advanced cancer.I am not currently in another study or have taken experimental drugs recently.I have another type of cancer that is currently active.I am about to receive my first chemotherapy for advanced or spread cancer.I have HIV, am on ART, and my infection is well-controlled.I can be treated with capecitabine, nab-paclitaxel, or paclitaxel.I've had treatments like PARP, PI3K, or mTOR inhibitors but can't have more hormone therapy.My cancer is not HER2 positive.I am not pregnant or breastfeeding.I am fully active or can carry out light work.I am currently taking antibiotics for a serious infection.My cancer has grown or spread on my last scan.I have a sufficient sample of my tumor from a recent or metastatic site.My cancer has worsened despite having at least two different hormone treatments.My cancer returned within 24 months while on initial hormone therapy with a CDK 4/6 inhibitor, and I can't have more hormone therapy for advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan-hziy (SG)
- Group 2: Treatment of Physician's Choice (TPC)
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.
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