Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor

NCT06996093 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SCHBCC-N087
• Study Type: interventional
• Target: 2,508
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.

Conditions

Breast Cancer

Keywords

adjuvant chemotherapy omission; adjuvant ribociclib

Outcome Measures

Primary Outcomes (1)

• invasive disease free survival

  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.

  4 years

Secondary Outcomes (4)

• distant disease free survival

  4 years

• overall survival

  4 years

• adverse effects

  4 years

• patient reported outcome

  4 years

Study Arms (2)

Arm #1: Endocrine+CDK4/6i

EXPERIMENTAL

aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor without chemotherapy

Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

Arm #2: TC*4-Endocrine+CDK4/6i

ACTIVE COMPARATOR

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy; Drug: aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

Interventions

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy DRUG

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Arm #2: TC*4-Endocrine+CDK4/6i

aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor DRUG

aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

Arm #1: Endocrine+CDK4/6i; Arm #2: TC*4-Endocrine+CDK4/6i

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males aged 18-70 years;
• ECOG performance status 0-1;
• Early-stage breast cancer, with postoperative pathology confirming invasive carcinoma, HR-positive and HER2-negative (In this study, HR-positive is defined as: ER-positive by IHC with \>10% tumor cells staining positive; HER2-negative defined as HER2 0-1+ by IHC or HER2++ with negative FISH result, without amplification);
• Postoperative pathological stage pT2N0M0 and:
• Histological grade 3, or Histological grade 2 with Ki67 ≥ 20% or high-risk multigene assay results;
• No prior neoadjuvant therapy received;
• Good postoperative recovery, with randomization occurring no more than 8 weeks after surgery;
• Normal function of major organs, meeting the following criteria:
• Hematological tests must meet: HB ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10⁹/L; PLT ≥100×10⁹/L; Biochemical tests must meet: TBIL ≤1.5×ULN (upper limit of normal); ALT and AST ≤3×ULN; serum Cr ≤1.5×ULN;
• Contraception required for male participants and women of childbearing potential during treatment;
• Participants voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.

You may not qualify if:

• Bilateral breast cancer or carcinoma in situ (DCIS/LCIS);
• Metastasis at any site;
• Clinical or imaging suspicion of malignancy in the contralateral breast requiring biopsy (unless ruled out);
• Prior neoadjuvant therapy, including chemotherapy, radiotherapy, or endocrine therapy;
• Use of tamoxifen, raloxifene, or aromatase inhibitors (AIs) for breast cancer risk reduction ("chemoprevention") and/or osteoporosis treatment within the past 2 years;
• History of other malignancies within the past 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix), including contralateral breast cancer;
• Concurrent participation in another clinical trial;
• Severe systemic diseases and/or uncontrolled infections that preclude study participation;
• Severe cardiovascular or cerebrovascular events within 6 months before randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke);
• Known hypersensitivity to the study drugs;
• Men and women of childbearing potential unwilling to use contraception during treatment and for 8 weeks after treatment completion;
• Pregnant or lactating women;
• Positive pregnancy test before study drug administration (for women of childbearing potential);
• Psychiatric disorders, cognitive impairment, or inability to comprehend the trial protocol, adverse effects, or comply with study procedures and follow-up (requires systematic evaluation before enrollment);
• Individuals lacking personal freedom or legal capacity for independent civil conduct.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Chemotherapy, Adjuvant; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Zhimin Shao, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, MD, PhD

CONTACT

+86-021-64175590; zhimingshao@yahoo.com

Wenjia Zuo, MD

CONTACT

+86-18017312648; wenjiaz07@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (MD, PhD)

Model Details: Arm #1: standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy Arm #2: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by standard endocrine therapy plus CDK4/6 inhibitor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 30, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2034
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)