Early Breast CancerPhase 2NCT06341894
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
A Phase 2 study testing Dalpiciclib and Endocrine therapy in people with Early Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Dalpiciclib and Endocrine therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,163 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2023to Jun 2029
- Phase
- Phase 2
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years-old
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
- Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
- Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
- From operation to enrollment should not exceed 12 months
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Who cannot join
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiaoan Liu, Professor, 025-68308162, liuxiaoan@126.com
About this study
Official title: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
- Conditions
- Early Breast Cancer
- Being tested
- Dalpiciclib, Endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Also called CDK4/6 inhibitor
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
Endocrine therapyDrug
Fulvestrant/AI
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Dalpiciclib and endocrine therapy Receives: Drug: Dalpiciclib; Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive Disease-free Survival (iDFS)
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
Measured: From enrollment until time of events up to 3 years
Secondary outcomes (2)
Disease-free Survival (DFS)
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
Measured: From enrollment until time of events up to 3 years
AEs and SAEs
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Measured: From the first administration to one months after the last drug administration，up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start17 Nov 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Xiaoan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341894
- Sponsor's protocol ID
- OBU-II-BC-126
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No