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AzTrials

Advanced Breast CancerPhase 3NCT05439499

This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.

A Phase 3 study testing FCN-437c, Letrozole or anastrozole, Goserelin acetate in people with Advanced Breast Cancer and Female Breast Cancer, run by Ahon Pharmaceutical Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of FCN-437c in combination with letrozole or anastrozole ± Goserelin versus placebo combined with letrozole or anastrozole ± Goserelin in women with first-line advanced breast cancer in HR+… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer, Female Breast Cancer
What is being tested?
FCN-437c, Letrozole or anastrozole, Goserelin acetate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
434 participants
Where
1 siteChina
Study dates
2 Mar 2022to 2 Mar 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following conditions:
  • Postmenopausal or premenopausal / peri-menopausal females aged≥18 years;
  • Postmenopausal female is defined as:
  • After bilateral oophorectomy; Age≥60 years Age<60 years and menopause for more than 1 year without chemotherapy and treatment with tamoxifen, toremifene and ovarian function suppression, while blood FSH and estradiol levels meet the postmenopausal range and for postmenopausal patients who are taking tamoxifen or toremifene and who are younger than 60 years old, continuous detection of serum FSH and estradiol levels must meet the postmenopausal range.
  • Females with advanced breast cancer diagnosed as HR+ HER2-。 HR+ positive is defined as：Histological and/or cytological confirmed ER+, PR + or -, defined as immunohistochemistry showing positive nuclear staining of estrogen/progesterone receptor tumor cells≥1%； HER2-negative is defined as：Histological and/or cytological confirmed HER2-， defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+,the ISH test result must be negative。
  • There should be evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy for curative purposes, and without clinical indications for chemotherapy;。
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  • Patients who have not received any systemic anticancer therapy for focal recurrent or metastatic disease（Patients who had received aromatase inhibitors for advanced breast cancer for no more than 28 days or Goserelin for no more than 28 days prior to randomization are eligible for enrollment）. Patients with disease-free survival greater than 12 months after completion of adjuvant endocrine therapy are allowed to be enrolled.,
  • ECOGperformance status 0-1。
  • According to the RECIST 1.1 criteria, patients must have at least one measurable lesion, or patients with only bone metastases, if no measurable lesions are present, must have at least one bone lesion predominantly lytic.
  • Note: If the lesion has received radiotherapy or other locoregional treatment, there must be imaging evidence of disease progression in the lesion after completion of treatment,and the lesion can be considered as a measurable lesion. For patients with no measurable lesion and only one osteolytic lesion, if the lesion was previously treated with radiotherapy, imaging evidence is needed to show the progression of bone lesions after radiotherapy..
  • Life expectancy is not less than 12 weeks;
  • Adequate marrow and organ function:
  • Leukocyte number ≥1.5 x 109/L,Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Hemoglobin ≥90 g/dL(not transfused within 14 days before randomization)
  • Platelet≥75 x 109/L
  • Total serum bilirubin ≤ 1.5× upper limit of normal (ULN) , total serum bilirubin≤3 x ULN in patients with Gilbert syndrome;
  • Aspartate aminotransferase (AST)and alanine aminotransferase (ALT) ≤2.5×ULN; for patients with liver metastases,both AST and ALT ≤5×ULN ;
  • Creatinine <1.5×ULN or creatinine clearance≥50 mL / min[Ccr = ((140- age) ×body weight (kg)) / (72× Scr (mg / dl)) or Ccr = ((140-age)× body weight (kg)) / (0.818× Scr (umol / L)) Note: Females were calculated ×0.85]
  • QTcF < 470 ms ；
  • For fertile patients: Patients should consent to abstinence or use of highly effective contraceptive methods such as IUDs, IUD system, bilateral tubal obstruction, and partner vasoligation, during treatment and for at least 90 days after the last dose of study treatment. Do not use hormonal contraceptives for contraception.
  • The patient is fully aware of the study and has signed an informed consent form (ICF), and is willing and able to comply with planned visits, treatment plans, laboratory examinations, and other trial procedures.

Who cannot join

  • Patients who meet any of the following conditions are not allowed to enter this clinical study：
  • Previously treated with CDK4 / 6 inhibitors;
  • Disease progression orrecurrence during or within 12 months after receiving neoadjuvant therapy or adjuvant therapy with endocrine drugs;
  • Received radiotherapy, chemotherapy, major surgery, tumor immunotherapy, monoclonal antitumor drug therapy, any investigational drug or other systemic anti-tumor therapy within 4 weeks before randomization;
  • Patients with important organ metastasis or large tumor burden that are not suitable for endocrine therapy. For example, according to the investigator, the patient is not suitable for endocrine therapy:
  • Symptomatic visceral metastasis;
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  • Rapid disease progression or impaired visceral function;
  • Non-visceral metastases requiring chemotherapy according to the investigator's clinical judgment。
  • Clinically suspected brain metastasis meningeal metastasis or unstable brain parenchymal metastasis, but stable brain metastasis can be enrolled. Stable brain metastasis is defined as: no expansion of the original metastatic lesions and no new lesions are found in the imaging reports at intervals of more than one month; No clinical symptoms, no need for hormone or other dehydrating treatment;
  • Inflammatory breast cancer
  • Presence of clinically uncontrolled pleural, pericardial, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to randomization).
  • Any other malignancy diagnosed within 3 years prior to participation in this study, except radically treated early stage malignancies (carcinoma in situ or stage I tumors) , such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
  • Persistent toxicities (NCI-CTCAE 5.0 Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia;
  • Within 6 months prior to study entry,, the following conditions have occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, ≥ grade 2 sustained arrhythmia (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bridging, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism;
  • Dysphagia, or active digestive disease, or major gastrointestinal surgery, or malabsorption syndrome, or other conditions that may impair the absorption of FCN-437C (e.g., ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome and small bowel resection)
  • Known to be allergic to letrozole, anastrozole, Goserelin,FCN-437C or any other excipients;
  • Patients with active infection, including those who are positive for hepatitis B surface antigen (HBsAg) and whose HBV DNA quantification is ≥ 1.00 x103 IU/ml；Hepatitis C antibody (anti-HCV) positive patients; patients infected with human immunodeficiency virus (HIV);
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Pregnant or lactating women;
  • Any other clinically significant disease or condition (such as uncontrolled diabetes, active or uncontrolled infection, etc.) that the investigator believes may affect protocol compliance or the ICF signature.

Trial locations and contacts

1 site in 1 country.

Xiaoran Yang contact

+86 13146214840

yangxiaoran@avancpharma.com

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Binghe Xu

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR-positive and HER2-negative Advanced Breast Cancer

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of FCN-437c in combination with letrozole or anastrozole ± Goserelin versus placebo combined with letrozole or anastrozole ± Goserelin in women with first-line advanced breast cancer in HR+ and HER2-.

Being tested
FCN-437c, Letrozole or anastrozole, Goserelin acetate, Placebo, Letrozole or anastrozole, Goserelin acetate
Keywords
HR receptor positive HER2 receptor negative

What participants receive

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

  • FCN-437c, Letrozole or anastrozole, Goserelin acetateDrug

    FCN-437c：available in 25mg and 100mg capsules for oral administration on an empty stomach. 200mg once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment until progressive disease。Letrozole or anastrozole：Letrozole 2.5 mg or anastrozole 1 mg once daily；Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。

  • Placebo, Letrozole or anastrozole, Goserelin acetateDrug

    Placebo：available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。

    Letrozole or anastrozole：Letrozole 2.5 mg or anastrozole 1 mg once daily；

    Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。

Study groups in NCT05439499
Study groupRoleWhat they receive
FCN-437c+Letrozole/anastrozole ± Goserelin acetateExperimentalNot described
Receives: Drug: FCN-437c, Letrozole or anastrozole, Goserelin acetate
Placebo+Letrozole/anastrozole ± Goserelin acetatePlacebo comparatorNot described
Receives: Drug: Placebo, Letrozole or anastrozole, Goserelin acetate

What is being measured

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

  1. PFS is determined by IRC

    Progression-free survival as determined by IRC based on RECIST V1.1

    Measured: 3 years

Timeline

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

  1. First posted30 Jun 2022
  2. Study start2 Mar 2022
  3. Primary completion20 Sep 2024 (estimated)
  4. Study completion2 Mar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
434 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05439499
Sponsor's protocol ID
FCN-437c-III201
Status last verified
Jun 2022
First submitted
24 Jun 2022
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan P, Liu Y, Li W, Li H, Tong Z, Cheng J, Zhang M, Shan J, Zhong J, Yi T, Liu J, Li H, Huang Z, Wu J, Ding S, Li L, Zong H, Jia H, Wang S, Wang K, Guo H, Ma L, Ouyang Z, Li H, Sun T, Lu P, Yang X, Wang X, Peng Y, Li L, Xu B; FCN-437c-III201 Investigators. Fovinaciclib for First-Line Therapy of Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2026 Jun 1:e261938. doi: 10.1001/jamaoncol.2026.1938. Online ahead of print.

    PubMed 42224659

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FCN-437c, Letrozole or anastrozole, Goserelin acetate in people with Advanced Breast Cancer and Female Breast Cancer, run by Ahon Pharmaceutical Co., Ltd. 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 21 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 6 Jul 2022. 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. Some participants in this study may receive a placebo. 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 Xiaoran Yang (+86 13146214840, yangxiaoran@avancpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS is determined by IRC (time frame: 3 years). 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 NCT05439499, which also lists 1 linked publication.

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 6 Jul 2022.

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