InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 3 November 2023

ASCENT-07: This study is evaluating whether targeted therapy is more effective than standard treatment in people with HR+, HER2- metastatic or advanced breast cancer who have had prior treatment with endocrine therapyA Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Clinical summary

Summary

This study is recruiting people with hormone receptor-positive (HR+)/ Human Epidermal Growth Factor 2-Negative (HER2-) inoperable, locally advanced or metastatic breast cancer who have had previous treatment with endocrine therapy. 

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm 1 (Experimental), participants will receive a type of targeted therapy called Sacituzumab Govitecan-hziy. This will be administered via an intravenous infusion on Days 1 and 8 of a 21-day cycle.

In Arm 2 (Active Comparator), participants will receive treatment of the physician's choice. This will be one of three chemotherapy regimens, either:

  • paclitaxel, administered as intravenous infusion on Days 1, 8 and 15 of a 28-day cycle.
  • nab-paclitaxel, administered as intravenous infusion on Days 1, 8 and 15 of a 28-day cycle.
  • capecitabine, administered orally twice daily for 2 weeks, followed by a 1-week rest period, in 28-day cycles.

Conditions

This trial is treating patients with HR+, HER2- breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

ASCENT-07

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT05840211
  • GS-US-598-6168; 2022-502593-17-00; JRCT2061230032; DOH-27-082023-6901; MOH_2023-07-17_012821

Trial sponsor

Gilead Sciences

Scientific Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Eligibility

Inclusion

  • Able to understand and give written informed consent.
  • Must have adequate tumor tissue sample from locally recurrent or metastatic site.
  • Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy from a locally recurrent or metastatic site.
  • Documented evidence of HER2- status.
  • Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
  • Candidate for the first chemotherapy in the locally advanced or metastatic setting.
  • Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
  • Individuals must have one of the following:

    • Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.

      • Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
    • Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting.
    • Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
  • Individuals may have received prior targeted therapies, including but not limited to phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations) or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
  • Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
  • Demonstrates adequate organ function.
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion

  • Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
  • Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
  • Current enrollment in another clinical study or use of any investigational device or drug either within 5 half-lives or 28 days prior to randomization, whichever is longer.
  • Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
  • Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
  • Have an active second malignancy.
  • Have an active serious infection requiring antibiotics.
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.