Breast CancerNCT06587789
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
An observational study of Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2027
- Phase
- Observational
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population who meet the above mentioned inclusions will be selected from cooperative hospitals.
Who may be able to join
- Before any trial-related procedures, sign a written informed consent, and be willing and able to follow the planned visits, research treatment, laboratory examination and other test procedures;
- Age 18-80 years old, female (both pre/post menopausal);
- The patient's initial diagnostic tissue specimens were confirmed to be HR+, HER2- early high-risk invasive breast cancer without evidence of disease recurrence or distant metastasis.
- The patient must have undergone radical surgery for the primary breast tumor. The cut edge of the removed specimen must be free from histological tumor residue (including invasive breast cancer or ductal carcinoma in situ [DCIS]). If supraclavicular or internal breast lymph nodes are considered for metastasis but cannot be surgically removed, radiotherapy should be carried out in the remaining lymph node drainage area in accordance with local guidelines.
- After surgical resection, the tumor was completely removed, and there was no tumor at the end of the surgical specimen microscope, and it belonged to one of the following stages:
- Pathological Stage IIB or III
Show all 18Show fewer
- Pathological Stage IIA as listed below:
- N1 or N0, and: grade 3, or grade 2, meeting any of the following criteria:
- ( Ki67 ≥ 20%, or Oncotype DX breast recurrence score ≥ 26, or MammaPrint classification of high risk)
- Attention:
- For patients with tumor anatomical stage IIA N0: Patients are ineligible if Grade 1 or Unknown (Gx).
- Patients receiving neoadjuvant therapy must meet the above criteria in any preoperative staging/samples and/or surgical specimens (for staging, if Stage IIA, N0, also including grading and Ki67 or gene expression testing).
- AJCC 8th edition anatomic staging requirements determine T, N, and M categories. ALND is the preferred method for axillary lymph node staging; however, SLN dissection may be used to determine N classification in the following situations: No metastasis in the SLN (patients are considered as pN0); Slight metastasis in the SLN (patient considered as pN1mi); Patients with T1-2 and no clinically significant nodes before surgery, no neoadjuvant chemotherapy, at least 1 macrometastasis in 1 or 2 SLNs, no clustered swollen lymph nodes or severe extra-lymph node diseases during SLN clearance (patients are considered as pN1).
- A maximum of 12 months from surgery to enrollment.
- Patients with an ECOG score of ≤3, allowing the combination of other asymptomatic underlying diseases.
- The patient can swallow oral endocrine drugs, regardless of the type of endocrine drugs.
- The patient agrees to take paraffin samples from the primary lesions (including the primary lesions and lymph nodes), tumor tissue and blood samples from the recurrent lesions for future exploratory biomarker analyses
- The patient has completed (neo)adjuvant chemotherapy and standard radiotherapy (when indicated) in accordance with clinical practice guidelines.
Who cannot join
- The patient has received any CDK4/6 inhibitors in the past.
- Metastatic diseases (including contralateral axillary lymph nodes)
- Patients have received ET (tamoxifen or aromatase inhibitors or raloxifene) for the prevention of breast cancer.
- Unwilling to participate in the quality of life questionnaire score or provide tissue samples at the time of recurrence
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
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Chao Ni, 086 13989463951, nicaho428@zju.edu.cn
About this study
Official title: A Multi-center, Prospective and Observational Study of Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. The main question it aims to answer is:
Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer? Participants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy for three years. During the follow-up, their relevant clinical data will be recorded.
Read the detailed description
In this multi-center, prospective and observational study, we aim to learn about the efficacy and safety of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. After being evaluated by the researchers as early high-risk HR+HER2- breast cancer patients, signing the informed consent, and being screened to meet the inclusion criteria, eligible participants will be enrolled to receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy. During there years of follow-up, their relevant clinical data will be recorded.
Enrolled patients are recommended to receive 3 years of ribociclib combined with ET, or until evidence of disease recurrence is observed or other discontinuation criteria are met (whichever occurs earliest).
ET will be administered during the observational phase of the study (3 years) according to the prescription selected by the physician. At the end of the research observation phase, according to medical indication, standard adjuvant ET should continue for 2-8 years, and the total treatment duration can be up to 10 years.
According to physician's choice, participants use the approved standard adjuvant ET (e.g., according to standard clinical practice, TAM or AI, with or without OFS). Fulvestrant should not be used for adjuvant therapy at any time during the study period.
Review of imaging (ultrasound,CT or MRI) of common recurrent sites throughout the body every 3 months before and after dosing, and every 6 months after 2 years until disease recurrence or death or the end of this study. This is the current follow-up interval recommended by the Chinese Anticancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications, Version 2024, which does not increase the burden of follow-up for patients.
Records of blood-related indicators (according to the instructions of ribociclib) (blood routine, biochemical indicators) were reviewed during the treatment follow-up. Medical staff, graduate students, and technicians complete the record of the patient-reported outcomes (PROs) (pre-drug and 1,3,6,12,18,24,36 months post-drug) in real time through mutiple questionnaire survey such as WeChat applets, phone calls, text messaging, and face-to-face visits.
The study will collect primary and recurrent metastatic tumor tissues and blood, using multi-gene detection, proteomic and other means to detect samples, and explore the biomarkers associated with ribociclib treatment.
This study is expected to have an enrollment time of 24 months and a follow-up time of 36 months.
- Conditions
- Breast Cancer
- Being tested
- Ribociclib
- Keywords
- Ribociclib, Breast Cancer, Adjuvant 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.
RibociclibDrug
Participants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy (according to standard clinical practice, TAM or AI, with or without OFS).
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib combined with endocrine therapy group | Patients with early high-risk HR+HER2- breast cancer will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy as adjuvant therapy. During three years of follow-up, their relevant clinical data will be recorded. Receives: Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival(iDFS)
iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Measured: 3 years
Secondary outcomes (6)
Distant recurrence-free survival(DRFS)
DRFS is defined as the time from date of randomization to date of first event of distant recurrence, or death (any cause).
Measured: 3 years
Distant disease-free survival(DDFS)
DDFS using STEEP criteria. DDFS is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Measured: 3 years
Overall Survival
OS is defined as the time from date of randomization to date of death due to any cause.
Measured: 3 years
Frequency of AE/SAE
Adverse Events assessed by investigator (type, frequency, severity (graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0)), seriousness)
Measured: 3 years
Quality of life by the Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline and 1,3,6,12,18,24,36 months after therapy
Quality of life by the Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. All of the scales and single-item measures range in score from 0 to 100. Higher scores typically indicate better quality of life, while lower scores may suggest poorer quality of life.
Measured: At baseline and 1,3,6,12,18,24,36 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Jinhua Central Hospital, Taizhou Hospital, Ningbo Medical Center Lihuili Hospital, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, Affiliated Zhoushan Hospital of Wenzhou Medical University, Zhejiang University, Sir Run Run Shaw Hospital, Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587789
- Sponsor's protocol ID
- 2024-0726
- Status last verified
- Jul 2024
- First submitted
- 27 Aug 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective and Observational Study of Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT06587789
- Acronym / sponsor ID
- 2024-0726
- Conditions
- Breast Cancer
- Keywords
- Ribociclib, Breast Cancer, Adjuvant Endocrine Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University, Jinhua Central Hospital, Taizhou Hospital, Ningbo Medical Center Lihuili Hospital, The Affiliated People's Hospital of Ningbo University, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, Affiliated Zhoushan Hospital of Wenzhou Medical University, Zhejiang University, Sir Run Run Shaw Hospital, Women's Hospital School Of Medicine Zhejiang University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the effects of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. The main question it aims to answer is:
Whether it is effective and safe to use ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer? Participants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy for three years. During the follow-up, their relevant clinical data will be recorded.
Detailed description
In this multi-center, prospective and observational study, we aim to learn about the efficacy and safety of using ribociclib in combination with physician-selected endocrine therapy as adjuvant therapy for patients with early high-risk HR+HER2- breast cancer. After being evaluated by the researchers as early high-risk HR+HER2- breast cancer patients, signing the informed consent, and being screened to meet the inclusion criteria, eligible participants will be enrolled to receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy. During there years of follow-up, their relevant clinical data will be recorded.
Enrolled patients are recommended to receive 3 years of ribociclib combined with ET, or until evidence of disease recurrence is observed or other discontinuation criteria are met (whichever occurs earliest).
ET will be administered during the observational phase of the study (3 years) according to the prescription selected by the physician. At the end of the research observation phase, according to medical indication, standard adjuvant ET should continue for 2-8 years, and the total treatment duration can be up to 10 years.
According to physician's choice, participants use the approved standard adjuvant ET (e.g., according to standard clinical practice, TAM or AI, with or without OFS). Fulvestrant should not be used for adjuvant therapy at any time during the study period.
Review of imaging (ultrasound,CT or MRI) of common recurrent sites throughout the body every 3 months before and after dosing, and every 6 months after 2 years until disease recurrence or death or the end of this study. This is the current follow-up interval recommended by the Chinese Anticancer Association Breast Cancer Diagnosis and Treatment Guidelines and Specifications, Version 2024, which does not increase the burden of follow-up for patients.
Records of blood-related indicators (according to the instructions of ribociclib) (blood routine, biochemical indicators) were reviewed during the treatment follow-up. Medical staff, graduate students, and technicians complete the record of the patient-reported outcomes (PROs) (pre-drug and 1,3,6,12,18,24,36 months post-drug) in real time through mutiple questionnaire survey such as WeChat applets, phone calls, text messaging, and face-to-face visits.
The study will collect primary and recurrent metastatic tumor tissues and blood, using multi-gene detection, proteomic and other means to detect samples, and explore the biomarkers associated with ribociclib treatment.
This study is expected to have an enrollment time of 24 months and a follow-up time of 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribociclib combined with endocrine therapy group | – | Drug: RibociclibPatients with early high-risk HR+HER2- breast cancer will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy as adjuvant therapy. During three years of follow-up, their relevant clinical data will be recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population who meet the above mentioned inclusions will be selected from cooperative hospitals.
Key inclusion criteria (18 listed)
- Before any trial-related procedures, sign a written informed consent, and be willing and able to follow the planned visits, research treatment, laboratory examination and other test procedures;
- Age 18-80 years old, female (both pre/post menopausal);
- The patient's initial diagnostic tissue specimens were confirmed to be HR+, HER2- early high-risk invasive breast cancer without evidence of disease recurrence or distant metastasis.
- The patient must have undergone radical surgery for the primary breast tumor. The cut edge of the removed specimen must be free from histological tumor residue (including invasive breast cancer or ductal carcinoma in situ [DCIS]). If supraclavicular or internal breast lymph nodes are considered for metastasis but cannot be surgically removed, radiotherapy should be carried out in the remaining lymph node drainage area in accordance with local guidelines.
- After surgical resection, the tumor was completely removed, and there was no tumor at the end of the surgical specimen microscope, and it belonged to one of the following stages:
Key exclusion criteria (4 listed)
- The patient has received any CDK4/6 inhibitors in the past.
- Metastatic diseases (including contralateral axillary lymph nodes)
- Patients have received ET (tamoxifen or aromatase inhibitors or raloxifene) for the prevention of breast cancer.
- Unwilling to participate in the quality of life questionnaire score or provide tissue samples at the time of recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibParticipants will receive ribociclib (at a dose of 400mg per day for 3 weeks, followed by 1 week off, 4 weeks for 1 cycle) plus physician-selected endocrine therapy (according to standard clinical practice, TAM or AI, with or without OFS). | Drug | Ribociclib combined with endocrine therapy group |
Primary outcome
Invasive Disease-Free Survival(iDFS)
Time frame: 3 years
iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
6 secondary outcomes
Distant recurrence-free survival(DRFS)
Time frame: 3 years
Distant disease-free survival(DDFS)
Time frame: 3 years
Overall Survival
Time frame: 3 years
Frequency of AE/SAE
Time frame: 3 years
Quality of life by the Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline and 1,3,6,12,18,24,36 months after therapy
Quality of life by the Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)
Time frame: At baseline and 1,3,6,12,18,24,36 months after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 18 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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.
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 Chao Ni (13989463951, nicaho428@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-Free Survival(iDFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.