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Breast CancerPhase 1/2NCT05574881

Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

A Phase 1/2 study testing Dalpiciclib, Fulvestrant and Pertuzumab in people with Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the efficacy and safety of Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR+/HER2+ Metastatic Breast Cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Dalpiciclib, Fulvestrant and Pertuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Jan 2025
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily joined the study, signed informed consent, and had good compliance.
  • Postmenopausal or premenopausal perimenopausal female patients aged ≥ 18 years, Meet one of the following:
  • Previous bilateral oophorectomy, or age ≥ 60 years; or Age <60, natural postmenopausal state (defined as regular months for at least 12 consecutive months After spontaneous cessation and no other pathological or physiological reasons), E2 and follicle stimulating hormone (FSH) in menopause Post-level; or Pre-menopausal or perimenopausal female patients can also be included, but must be willing to receive treatment with luteinizing hormone releasing hormone (LHRH) agonists;
  • Patients with HR+/HER2+ recurrent or metastatic breast cancer confirmed by histopathology； HER2 positivity is defined by standard of 3+ staining by immunohistochemical staining (IHC) or positive for in situ hybridization (ISH)； Estrogen receptor (ER) or Progesterone receptor (PR) positive is defined as the percentage of cells positive for ER or PR expression ≥ 10%； Local recurrence needs to be confirmed by the physician that is unresectable
  • At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
  • No systemic treatment in metastatic setting. At least 12-month interval between the time of last dose of trastuzumab in adjuvant treatment and the date of diagnosis with recurrent or metastatic breast cancer
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  • Had received endocrine therapy in adjuvant setting.
  • Eastern Cooperative Oncology Group Performance Status of 0-1.
  • Life expectancy ≥ 12 weeks.
  • Adequate function of major organs meets the following requirements (no blood components and cell growth factors have been used within 14 days before randomization):
  • Neutrophils ≥ 1.5×10^9/L， Platelets ≥ 100×10^9/L， Hemoglobin ≥ 90g/L， Total bilirubin≤ 1.5 × the upper limit of normal (ULN)， Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN， blood urea nitrogen(BUN) and Cr ≤ 1.5 × ULN， Left ventricular ejection fraction (LVEF) ≥ 50%， QTcF(Fridericia correction) ≤ 470 ms， International normalized ratio(INR)≤1.5 × ULN， activated partial thromboplastin time(APTT) ≤ 1.5 × ULN

Who cannot join

  • Meningeal metastasis or active brain parenchymal metastasis. Patients with clinically stable brain parenchymal metastases can be included, including asymptomatic brain metastases that have not received local treatment; or patients who have previously received central nervous system metastasis therapy (radiotherapy or surgery), if imaging confirms that stability has been maintained for at least 4 weeks, and have stopped symptomatic treatment (including hormones and mannitol, etc.) for more than 2 weeks
  • Visceral crisis.
  • Previously received any CDK4/6 inhibitor treatment.
  • Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug.
  • Patients with other malignant tumors within 5 years or at the same time( except for cured skin basal cell carcinoma and cervical carcinoma in situ).
  • Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
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  • Pregnant women, lactating female, or women of childbearing age who are unwilling to take effective contraceptive measures.
  • Have a history of allergies to the drug components of this regimen.
  • Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method).
  • History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
  • History of cardiac dysfunction, include (1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥ grade 2 found in screening.
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  • Childbearing female who refuses to accept any contraception practice.
  • Determined by the physician, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,active infection etc.).
  • History of neurological or psychiatric disorders, including epilepsy or dementia.
  • Severe infections within 4 weeks prior to first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical protocols), or unexplained fever (T > 38.3 °C ) during screening or prior to first administration.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Prospective, Single Center, Phase II Trial of Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

To investigate the efficacy and safety of Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR+/HER2+ Metastatic Breast Cancer

Conditions
Breast Cancer
Being tested
Dalpiciclib, Fulvestrant, Pertuzumab, Trastuzumab
Keywords
HR positive, HER2 positive Metastatic Breast Cancer, Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab
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

    150 mg qd

  • FulvestrantDrug

    500mg d1, 15, 29, and then q4w

  • PertuzumabDrug

    840mg q3w, and then 420 mg q3w

  • TrastuzumabDrug

    8 mg/kg q3w, and then 6 mg/kg q3w

Study groups in NCT05574881
Study groupRoleWhat they receive
Arm1ExperimentalDalpiciclib 150 mg qd; Fulvestrant 500mg d1, 15, 29, and then q4w; Pertuzumab 840mg q3w, and then 420 mg q3w; Trastuzumab 8 mg/kg q3w, and then 6 mg/kg q3w
Receives: Drug: Dalpiciclib; Drug: Fulvestrant; Drug: Pertuzumab; Drug: Trastuzumab

What is being measured

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

  1. Progression-Free Survival (PFS)

    Progression free survival

    Measured: 6 weeks

Secondary outcomes (5)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety

    Measured: 6 weeks

  2. Objective response rate (ORR)

    Proportion of subjects whose efficacy was evaluated as Complete Response(CR)/PR

    Measured: 6 weeks

  3. Clinical benefit rate (CBR)

    Proportion of subjects with CR, PR and SD≥24 weeks during the study

    Measured: 6 weeks

  4. Duration of remission (DoR)

    The time from the first assessment of CR or PR to the first assessment of Progressive Disease(PD) or death from any cause；

    Measured: 6 weeks

  5. Overall Survival (OS)

    Measured: 6 weeks

Timeline

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

  1. First posted12 Oct 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574881
Sponsor's protocol ID
YOUNGBC-22
Status last verified
Feb 2024
First submitted
5 Oct 2022
Last updated
26 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dalpiciclib, Fulvestrant and Pertuzumab 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 11 inclusion and 16 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 26 Feb 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 6 weeks). 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 NCT05574881.

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 26 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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