Advanced Breast CancerPhase 3NCT05861830
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
A Phase 3 study testing The combination of Dalpiciclib with physician-selected endocrine therapy and Chemotherapy selected by the physician in people with Advanced Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- The combination of Dalpiciclib with physician-selected endocrine therapy and Chemotherapy selected by the physician
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The recent pathology results showed HR-positive and HER2-negative.
- 18F-FES-PET/CT showed at least one ER-positive lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2 points.
- Expected survival time ≥ 3 months.
- Previous antitumor therapy: (1) (neo)adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib or relapse after adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib; (2) receiving Palbociclib or Abemaciclib or Ribociclib-based treatment in the context of metastatic breast cancer or disease progression after treatment; (3) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; (4) previously received ≤3 lines of endocrine therapy for recurrent or metastatic breast cancer.
- Willing to undergo 18F-FDG PET/CT standard imaging.
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- At least one measurable lesion outside the skull according to RECIST V1.1.
- The function of important organs meets the requirements.
- The subjects have recovered from any adverse event related to previous tumor treatment (≤ Grade 1) before the first administration of the investigational drug.
Who cannot join
- 18F-FES-PET/CT shows that all lesions are ER-negative.
- Previously received treatment with Dalpiciclib.
- MRI or lumbar puncture confirms leptomeningeal metastasis.
- Imaging confirms central nervous system metastasis.
- Participants with visceral crisis, rapid disease progression, and patients not suitable for endocrine therapy.
- Participants with ascites, baseline pleural effusion with clinical symptoms, and pericardial effusion requiring drainage within the first 4 weeks of treatment.
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- Unable to swallow, intestinal obstruction, or other factors that affect drug administration and absorption.
- Participants diagnosed with any other malignancy within the past 5 years, excluding non-melanoma skin cancer treated with curative intent. Basal cell or squamous cell skin cancer, or cervical intraepithelial neoplasia and papillary thyroid cancer.
- Participants who have undergone major surgery or suffered a major injury within 4 weeks before starting treatment, or are expected to undergo major surgical treatment.
- Known history of allergy to the components of this treatment regimen.
Trial locations and contacts
1 site in 1 country.
Qiang Sun, M.D. contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Bo Pan, M.D., +86-133-6617-1269, panbopumc@163.com
Qiang Sun, M.D., sunqiang_pumc@163.com
About this study
Official title: An Exploratory Study on Predicting the Efficacy of Dalpiciclib in Combination With Endocrine Therapy for HR-Positive and HER2-Negative Recurrent/Metastatic Breast Cancer Patients After CDK4/6 Inhibitor Treatment Failure Using 18F-FES PET/CT
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.
Read the detailed description
With the emergence of targeted therapies, the treatment landscape for patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer (MBC) is continuously evolving. The combination of cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) with endocrine therapy has become the standard treatment approach for first-line therapy or treatment after progression on endocrine therapy. Multiple large randomized studies have demonstrated that the combination of CDK4/6i and endocrine therapy significantly improves progression-free survival (PFS) in HR+/HER2- MBC patients. Updated analyses have also shown a significant improvement in overall survival (OS) with the combination of endocrine therapy and either Palbociclib or Ribociclib. Currently, regulatory agencies have approved four CDK4/6 inhibitors, namely Palbociclib, Abemaciclib, Ribociclib, and Dalpiciclib, for the treatment of HR+/HER2- breast cancer. All four CDK4/6 inhibitors are approved for use in combination with endocrine therapy for advanced HR+/HER2- breast cancer. Abemaciclib has also been approved for use as adjuvant therapy in early-stage breast cancer with HR+/HER2- subtype and high-risk recurrent factors, as well as for the treatment of advanced breast cancer.
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. Despite the extensive clinical experience with these drugs, our understanding of the long-term effects of CDK4/6 blockade in patients previously treated with CDK4/6 inhibitors is limited. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival.
18F-fluorodeoxyglucose (FDG) PET imaging is widely utilized in the field of oncology to detect increased glucose metabolism activity. In the case of breast cancer, 18F-FDG PET/CT imaging is predominantly recommended for patients with unclear staging, advanced disease, or metastasis, when conventional imaging methods are inconclusive. On the other hand, 18F-fluoroestradiol (FES) is an endogenous estrogen analogue that specifically binds to estrogen receptors (ERs). Through PET imaging, FES enables dynamic, quantitative, and non-invasive assessment of ER expression levels and distribution within the patient's body. When combined with 18F-FDG PET or other imaging modalities, 18F-FES PET imaging can evaluate the heterogeneity of ER expression and has the potential to identify ER loss or dysfunction. It has been observed that 18F-FES PET exhibits good correlation with traditional immunohistochemistry for assessing ER expression. Moreover, published human studies have not reported any toxicity or adverse reactions associated with 18F-FES usage. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.
- Conditions
- Advanced Breast Cancer
- Being tested
- The combination of Dalpiciclib with physician-selected endocrine therapy, Chemotherapy selected by the physician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The combination of Dalpiciclib with physician-selected endocrine therapyDrug
- Dalpiciclib: 150 mg, orally, once daily, on days 1-21, every 28 days (3 weeks on, 1 week off)
- Letrozole: 2.5 mg, orally, once daily (continuous), every 28 days OR Anastrozole: 1.0 mg, orally, once daily (continuous), every 28 days OR Exemestane: 25 mg, orally, once daily (continuous), every 28 days OR Fulvestrant: 500 mg, intramuscular injection on day 1/15 of the first cycle, then on day 1 of each subsequent cycle, every 28 days OR Tamoxifen: 10-20 mg, orally, twice daily (continuous), every 28 days
- Pre/perimenopausal women also require ovarian function suppression (OFS), which can be achieved through bilateral oophorectomy or the use of gonadotropin-releasing hormone (GnRH) analog drugs
Chemotherapy selected by the physicianDrug
The chemotherapy regimen is chosen by the clinical physician and may include, but is not limited to, the following options: the combination of paclitaxel and capecitabine, the combination of paclitaxel and carboplatin, single-agent capecitabine, single-agent platinum drugs, and the combination of gemcitabine and platinum-based chemotherapy. Each treatment cycle consists of a 21-day duration.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | The combination of Dalpiciclib with physician-selected endocrine therapy Receives: Drug: The combination of Dalpiciclib with physician-selected endocrine therapy |
| Arm B | Active comparator | Chemotherapy selected by the physician Receives: Drug: Chemotherapy selected by the physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed PFS
The time from the initiation of treatment to the first radiographic assessment of disease progression (PD) or any event leading to death
Measured: Up to approximately 24 months
Secondary outcomes (3)
Objective Response Rate (ORR)
Objective Response Rate
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Disease Control Rate
Measured: Up to approximately 24 months
Overall Survival (OS)
Overall Survival
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start15 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qiang Sun, M.D., Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861830
- Sponsor's protocol ID
- PekingUMCH-FES-BC-2
- Status last verified
- Mar 2024
- First submitted
- 7 May 2023
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Predicting the Efficacy of Dalpiciclib in Combination With Endocrine Therapy for HR-Positive and HER2-Negative Recurrent/Metastatic Breast Cancer Patients After CDK4/6 Inhibitor Treatment Failure Using 18F-FES PET/CT
- ClinicalTrials.gov ID
- NCT05861830
- Acronym / sponsor ID
- PekingUMCH-FES-BC-2
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 May 2023 (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.
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.
Detailed description
With the emergence of targeted therapies, the treatment landscape for patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) metastatic breast cancer (MBC) is continuously evolving. The combination of cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) with endocrine therapy has become the standard treatment approach for first-line therapy or treatment after progression on endocrine therapy. Multiple large randomized studies have demonstrated that the combination of CDK4/6i and endocrine therapy significantly improves progression-free survival (PFS) in HR+/HER2- MBC patients. Updated analyses have also shown a significant improvement in overall survival (OS) with the combination of endocrine therapy and either Palbociclib or Ribociclib. Currently, regulatory agencies have approved four CDK4/6 inhibitors, namely Palbociclib, Abemaciclib, Ribociclib, and Dalpiciclib, for the treatment of HR+/HER2- breast cancer. All four CDK4/6 inhibitors are approved for use in combination with endocrine therapy for advanced HR+/HER2- breast cancer. Abemaciclib has also been approved for use as adjuvant therapy in early-stage breast cancer with HR+/HER2- subtype and high-risk recurrent factors, as well as for the treatment of advanced breast cancer.
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. Despite the extensive clinical experience with these drugs, our understanding of the long-term effects of CDK4/6 blockade in patients previously treated with CDK4/6 inhibitors is limited. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival.
18F-fluorodeoxyglucose (FDG) PET imaging is widely utilized in the field of oncology to detect increased glucose metabolism activity. In the case of breast cancer, 18F-FDG PET/CT imaging is predominantly recommended for patients with unclear staging, advanced disease, or metastasis, when conventional imaging methods are inconclusive. On the other hand, 18F-fluoroestradiol (FES) is an endogenous estrogen analogue that specifically binds to estrogen receptors (ERs). Through PET imaging, FES enables dynamic, quantitative, and non-invasive assessment of ER expression levels and distribution within the patient's body. When combined with 18F-FDG PET or other imaging modalities, 18F-FES PET imaging can evaluate the heterogeneity of ER expression and has the potential to identify ER loss or dysfunction. It has been observed that 18F-FES PET exhibits good correlation with traditional immunohistochemistry for assessing ER expression. Moreover, published human studies have not reported any toxicity or adverse reactions associated with 18F-FES usage. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: The combination of Dalpiciclib with physician-selected endocrine therapyThe combination of Dalpiciclib with physician-selected endocrine therapy |
| Arm B | Active comparator | Drug: Chemotherapy selected by the physicianChemotherapy selected by the physician |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The recent pathology results showed HR-positive and HER2-negative.
- 18F-FES-PET/CT showed at least one ER-positive lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2 points.
- Expected survival time ≥ 3 months.
- Previous antitumor therapy: (1) (neo)adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib or relapse after adjuvant treatment with Palbociclib or Abemaciclib or Ribociclib; (2) receiving Palbociclib or Abemaciclib or Ribociclib-based treatment in the context of metastatic breast cancer or disease progression after treatment; (3) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; (4) previously received ≤3 lines of endocrine therapy for recurrent or metastatic breast cancer.
Key exclusion criteria (10 listed)
- 18F-FES-PET/CT shows that all lesions are ER-negative.
- Previously received treatment with Dalpiciclib.
- MRI or lumbar puncture confirms leptomeningeal metastasis.
- Imaging confirms central nervous system metastasis.
- Participants with visceral crisis, rapid disease progression, and patients not suitable for endocrine therapy.
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 |
|---|---|---|
| The combination of Dalpiciclib with physician-selected endocrine therapy* Dalpiciclib: 150 mg, orally, once daily, on days 1-21, every 28 days (3 weeks on, 1 week off) * Letrozole: 2.5 mg, orally, once daily (continuous), every 28 days OR Anastrozole: 1.0 mg, orally, once daily (continuous), every 28 days OR Exemestane: 25 mg, orally, once daily (continuous), every 28 days OR Fulvestrant: 500 mg, intramuscular injection on day 1/15 of the first cycle, then on day 1 of each subsequent cycle, every 28 days OR Tamoxifen: 10-20 mg, orally, twice daily (continuous), every 28 days * Pre/perimenopausal women also require ovarian function suppression (OFS), which can be achieved through bilateral oophorectomy or the use of gonadotropin-releasing hormone (GnRH) analog drugs | Drug | Arm A |
| Chemotherapy selected by the physicianThe chemotherapy regimen is chosen by the clinical physician and may include, but is not limited to, the following options: the combination of paclitaxel and capecitabine, the combination of paclitaxel and carboplatin, single-agent capecitabine, single-agent platinum drugs, and the combination of gemcitabine and platinum-based chemotherapy. Each treatment cycle consists of a 21-day duration. | Drug | Arm B |
Primary outcome
Investigator-assessed PFS
Time frame: Up to approximately 24 months
The time from the initiation of treatment to the first radiographic assessment of disease progression (PD) or any event leading to death
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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. This study is not recruiting at the moment.
Qiang Sun, M.D. contact
Qiang Sun, M.D. study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The combination of Dalpiciclib with physician-selected endocrine therapy and Chemotherapy selected by the physician in people with Advanced Breast Cancer, run by Peking Union Medical College Hospital 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Pan, M.D. (+86-133-6617-1269, panbopumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed PFS (time frame: Up to approximately 24 months). 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 12 Mar 2024.