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Breast CancerPhase 2RACENCT07423611

ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer

A Phase 2 study testing Aromatase inhibitor (± ovarian suppression) plus Ribociclib and 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy in people with Breast Cancer, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Aromatase inhibitor (± ovarian suppression) plus Ribociclib and 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
1 siteChina
Study dates
1 Oct 2026to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure
  • Patient is female with known menopausal status at the time of randomization
  • Patient is ≥ 18 and ≤70 years-old at the time of PICF signature.
  • Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis
  • Patient has breast cancer that is positive for ER and/or PgR as determined on the most recently analyzed tissue sample
  • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample).
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  • Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
  • 1) T0-2N1, 2) T3-4N0, 3) T2N0 meeting the following criteria:
  • histological Grade 3,
  • histological Grade 2 with Ki-67 proliferation index ≥20% or/and high genomic risk 8. Eligible to adjuvant chemotherapy per investigator's decision (Based on clinicopathological findings or genomic assay results) 9. ECOG Performance Status of 0 or 1 10. ctDNA-MRD negative within 4 weeks post-surgery 11. Adequate hematological, renal, and hepatic function

Who cannot join

  • Prior neoadjuvant or adjuvant systemic treatment (including chemotherapy, targeted therapy, or endocrine therapy) for breast cancer
  • Bilateral breast cancer
  • Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery
  • Patient has other active malignancies within the past 2 years
  • Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
  • Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
  • Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 Grade ≤ 1 at day of randomization
  • Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Keda Yu, MD, PhD contact

86-21-64175590-88808

yukeda@fudan.edu.cn

Wenjia Zuo, MD contact

+86-18017312648

wenjiaz07@126.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Keda Yu, MD, PhD, 86-21-64175590-88808, yukeda@fudan.edu.cn

    Wenjia Zuo, MD, +86-18017312648 ext 67724, wenjiaz07@126.com

Other trials in China

About this study

Official title: A Multicenter, Open-label, Randomized Controlled Clinical Study Comparing the Efficacy and Safety of ctDNA-guided Ribociclib Plus Endocrine Therapy Versus Chemotherapy Followed by Ribociclib Plus Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Read the detailed description

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Patients with HR+/HER2- early breast cancer who have undergone definitive surgery will be enrolled and must undergo ctDNA-MRD analysis within 4 weeks after surgery. Patients who are ctDNA negative will be randomly assigned (1:1) to two study groups, according to stratification factors: menopausal status (premenopausal vs. postmenopausal). The experimental group will receive ribociclib plus aromatase inhibitor (AI) or ovarian function suppression (OFS), while the control group will receive chemotherapy followed by ribociclib plus AI or OFS. The safety and efficacy of each group will be assessed through ctDNA nagative rate, invasive disease free survival (iDFS), and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and patient reported outcome (PRO).

Conditions
Breast Cancer
Being tested
Aromatase inhibitor (± ovarian suppression) plus Ribociclib, 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
Keywords
ribociclib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aromatase inhibitor (± ovarian suppression) plus RibociclibDrug

    Aromatase inhibitor (± ovarian suppression) plus Ribociclib

  • 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapyDrug

    4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Study groups in NCT07423611
Study groupRoleWhat they receive
Arm #1: Endocrine+RibocilcibExperimentalAromatase inhibitor (± ovarian suppression) plus Ribocilcib without chemotherapy
Receives: Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib
Arm #2: TC*4→Endocrine+RibocilcibActive comparator4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus Ribocilcib
Receives: Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib; Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ctDNA negativity rate

    Definition of ctDNA negativity: Up to the assessment time point, no ctDNA-positive result has been reported. A patient is considered ctDNA-positive if at least one clinically significant mutation is detected, or if at least two variants of uncertain significance (VUS) are detected.

    3-year ctDNA negativity rate: (n1 - n2) / n1

    n1: total number of enrolled patients in each treatment group n2: number of patients in each treatment group who convert to ctDNA-positive on any test within 3 years

    Measured: 3 years

Secondary outcomes (3)

  1. Invasive disease free survival (IDFS)

    Invasive disease-free survival (IDFS), defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.

    Measured: 3 years

  2. Adverse effects(AEs)

    Adverse effects graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0

    Measured: 3 years

  3. Patient reported outcome(PRO)

    Information about a patient's health that comes directly from the patient. Examples of patient-reported outcomes include a patient's description of their symptoms, their satisfaction with care, and how a disease or treatment affects their physical, mental, emotional, spiritual, and social well-being. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
388 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07423611
Sponsor's protocol ID
CLEE011A0CN03T
Acronym
RACE
Status last verified
Feb 2026
First submitted
14 Feb 2026
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aromatase inhibitor (± ovarian suppression) plus Ribociclib and 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy in people with Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Keda Yu, MD, PhD (86-21-64175590-88808, yukeda@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ctDNA negativity rate (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07423611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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