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Sacituzumab Govitecan for Breast Cancer (ASCENT-07 Trial)
ASCENT-07 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).
ASCENT-07 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASCENT-07 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ASCENT-07 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Sacituzumab Govitecan-hziy (SG)
- Group 2: Treatment of Physician's Choice (TPC)
- 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.
- 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.
Frequently Asked Questions
Is this scientific research presently recruiting participants?
"Clinicaltrials.gov's records display that this study is presently looking for participants. This research was first put up on May 1st of 2023 and has since been tweaked April 21st, 2023."
What is the total number of participants in this research project?
"Indeed, according to information on clinicaltrials.gov this trial is currently in the recruitment process. The initial posting for this medical study was made on May 1st 2023 and it has been revised as recently as April 21st 2023. 654 participants need to be enrolled from two separate sites."
Has Sacituzumab Govitecan-hziy (SG) satisfied the requirements for FDA authorization?
"After assessing the available evidence, our team has assigned Sacituzumab Govitecan-hziy (SG) a safety score of 3 as this is an advanced phase trial that provides data supporting both efficacy and security."
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