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Breast CancerPhase 2abemaSNF1/3NCT06561022

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

A Phase 2 study testing Fluzoparib, Everolimus and Fulvestrant 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 The sponsor has not verified this record for over two years, so it may be out of date.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 explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs. Fulvestrant combined with Abemaciclib in patients with HR+/HER2- breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Fluzoparib, Everolimus and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
21 Aug 2024to 30 Jun 2026
Phase
Phase 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be enrolled in this study:
  • Females aged ≥ 18 years and ≤ 70 years.
  • Histologically confirmed HR-positive HER2-negative (specific definition: tumors are defined as ER positive when ≥ 1% tumor cells are positive by immunohistochemistry (IHC), and tumors are defined as HER2 negative when HER2 is 0-1+ or HER2 is ++ but the FISH or CISH result is negative and no amplification) locally advanced breast cancer (no radical local treatment is possible) or recurrent metastatic breast cancer with digital pathological staging of SNF1 or SNF3 subtype.
  • Progression after CDK 4/6 inhibitor treatment. If CDK 4/6 inhibitors are used in the adjuvant treatment, metastatic relapse should occur during the administration of CDK 4/6 inhibitor or within 12 months after the end of the administration. If CDK 4/6 inhibitors are used in the first-line treatment for metastatic relapse, disease progression should occur during the administration.
  • Have received ≤ first-line systemic therapy after metastatic relapse.
  • Have at least one assessable lesion according to RECIST version 1.1.
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  • The patient has adequate organ function for all of the following criteria, as defined below:
  • Hematologic: HB ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 109 /L; PLT ≥ 100 × 109 /L.
  • Hepatic: TBIL ≤ 1.5 × ULN (upper limit of normal) Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted. ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault formula).
  • Have not received endocrine therapy, targeted therapy, and surgery within 3 weeks prior to the start of the study and have recovered from acute toxic reactions to previous treatment (if surgery was performed, the wound has fully healed).
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
  • The patient is able to swallow oral medications.
  • ECOG score ≤ 1 and life expectancy ≥ 3 months.
  • Female subjects of childbearing potential are required to use a medically approved contraceptive measure during the study treatment and for at least 3 months after the last dose of investigational drug.
  • Subjects are voluntarily enrolled in this study, have signed informed consent form, have good compliance and cooperate with follow-up.

Who cannot join

  • Patients with any of the following could not be enrolled in this study:
  • Use of radiotherapy within 3 weeks prior to treatment.
  • Patients with known CNS metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, enhanced CT or enhanced magnetic resonance imaging (MRI) must be performed within 28 days prior to the first dose to rule out CNS metastases.
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
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  • ≥ grade 1 adverse reactions due to previous treatment that are still ongoing. Exceptions are alopecia or the cases that, in the opinion of the investigator, should not be excluded. Such cases should be clearly documented in the investigator's notes.
  • The patient has had major surgery within 14 days prior to randomization.
  • Females who are pregnant or lactating.
  • Malignant tumor within the past five years (except cured basal-cell carcinoma and cervical carcinoma in situ)
  • Inability to swallow, chronic diarrhoea and intestinal obstruction, and the presence of multiple factors that affect the administration and absorption of medication.
  • Presence of third spacing that cannot be controlled by drainage or other methods (e.g., large amounts of pleural effusion and ascites).
  • Non-healing wounds for a long time or fractures that are not fully healed.
  • Allergic individuals, or those with a known history of allergy to the components of the drug involved in this protocol.
  • Long-term use of oral steroid hormones. For occasional use in the past, a 4-week discontinuation period is required before enrollment.
  • Previous use of PAM pathway inhibitors such as Everolimus and PARP inhibitors such as Fluzoparib.
  • Use of any chemotherapy drugs during metastatic relapse.
  • Have received specific regimen of Abemaciclib combined with Fulvestrant during metastatic relapse (i.e., the control group in this study).
  • Have received CDK 4/6 inhibitors for > 1 treatment period.
  • The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.

Trial locations and contacts

1 site in 1 country.

Zhimin C Shao, MD, PhD contact

02164175590

zhimingshao@yahoo.com

Yin Liu, MD contact

02164175590

liuyinfudan@163.com

China1 site

  • 270 Dongan Road, Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

To explore the efficacy and safety of Everolimus (SNF1 subtype) or Fluzoparib (SNF3 subtype) combined with Fulvestrant and Abemaciclib vs. Fulvestrant combined with Abemaciclib in patients with HR+/HER2- breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment.

Read the detailed description

This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of a three-drug combination of Everolimus or Fluzoparib plus Fulvestrant and Abemaciclib compared to a two-drug combination of Fulvestrant plus Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1/SNF3 subtype who have progressed after CDK 4/6 inhibitor treatment. The study consists of Safety Lead-in phase, which aims to explore the safety and preliminary efficacy of the three-drug combination, and phase II, which aims to explore the efficacy of the three-drug combination.

Conditions
Breast Cancer
Being tested
Fluzoparib, Everolimus, Fulvestrant, Abemaciclib
Keywords
abemeciclib, subtyping -based medicine, post-CDK4/6 inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06561022
Study groupRoleWhat they receive
SNF 1 safety lead-in phaseExperimentalEverolimus plus Fulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Everolimus; Drug: Fulvestrant; Drug: Abemaciclib
SNF 1 Phase II ControlActive comparatorFulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Fulvestrant; Drug: Abemaciclib
SNF 1 Phase II ExperimentalExperimentalEverolimus plus Fulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF1 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Everolimus; Drug: Fulvestrant; Drug: Abemaciclib
SNF 3 safety lead-in phaseExperimentalFluzoparib plus Fulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF3 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Fluzoparib; Drug: Fulvestrant; Drug: Abemaciclib
SNF 3 Phase II ControlActive comparatorFulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF3 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Fulvestrant; Drug: Abemaciclib
SNF 3 Phase II ExperimentalActive comparatorFluzoparib plus Fulvestrant and Abemaciclib in patients with HR+ HER2-advanced breast cancer of SNF3 subtype who have progressed after CDK4/6 inhibitor treatment.
Receives: Drug: Fluzoparib; Drug: Fulvestrant; Drug: Abemaciclib

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0( Safety lead-in Phase)

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

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  2. objective response rate (ORR)( Safety lead-in Phase)

    objective response rate (ORR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  3. Progression-free survival (PFS)(Phase II)

    Progression-free survival (PFS)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

Secondary outcomes (8)

  1. Overall survival (OS)(Phase II)

    Overall survival (OS)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  2. objective response rate (ORR)(Phase II)

    objective response rate (ORR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  3. clinical benefit rate (CBR)(Phase II)

    clinical benefit rate (CBR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  4. duration of response (DOR)(Phase II)

    duration of response (DOR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  5. time to first response (TTR)(Phase II)

    time to first response (TTR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Phase II)

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

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  7. Clinical benefit rate (CBR)( Safety lead-in Phase)

    Clinical benefit rate (CBR)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

  8. Progression-free survival (PFS)( Safety lead-in Phase)

    Progression-free survival (PFS)

    Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

Timeline

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

  1. First posted19 Aug 2024
  2. Study start21 Aug 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561022
Sponsor's protocol ID
SCHBCC-N038
Acronym
abemaSNF1/3
Status last verified
Aug 2024
First submitted
21 Jul 2024
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib, Everolimus and Fulvestrant 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 16 inclusion and 20 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 19 Aug 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 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?

Contact Zhimin C Shao, MD, PhD (02164175590, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0( Safety lead-in Phase) (time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months). The study lists 3 primary outcomes in all. 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 NCT06561022.

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 19 Aug 2024.

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