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Breast NeoplasmsPhase 2NCT05004142

Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin

A Phase 2 study testing FCN-437c+Fulvestrant and FCN-437c+Letrozole+Goserelin in people with Breast Neoplasms, 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 The sponsor has not verified this record for over two years, so it may be out of date.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, open-label clinical study to evaluate the safety and antitumor activity of FCN-437c in combination with Fulvestrant for the treatment of post-menopausal female patients with ER+ and HER2- advanced breast cancer, FCN-437c in combination with Letrozole + Goserelin for the treatment of… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
FCN-437c+Fulvestrant and FCN-437c+Letrozole+Goserelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
30 Jun 2020to 30 Jun 2023
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are eligible to be included in the study only if they meet all of the following criteria:
  • Patients with advanced breast cancer diagnosed as ER+, HER2-; ER+ is defined as histologically or cytologically confirmed ER+ with positive nuclear staining of estrogen receptor tumor cells ≥ 1% by immunohistochemistry; HER2- is defined as histologically or cytologically confirmed HER2-, with a negative ISH test result or an IHC test result of 0, 1+, or 2+, and if the IHC test result is 2+, the ISH test result must be negative;
  • Criteria of menopausal status and prior treatment, and see Appendix 3 for definition of menopause:
  • Cohort 1 (FCN-437c in combination with Fulvestrant): post-menopausal patients with advanced breast cancer, who are not suitable for curative surgical resection or radiation therapy and have not previously received systemic therapy, or have disease progression supported by imaging evaluation during their first-line endocrine therapy (including anti-estrogen or aromatase inhibitors).
  • Cohort 2 (FCN-437c in combination with Letrozole + Goserelin): pre-menopausal patients with advanced breast cancer, who are not suitable for curative surgical resection or radiation therapy and have not received systemic therapy; Note: If any relapse or metastases occur within 12 months from the treatment start during the (neo) adjuvant endocrine therapy or within 12 months after the (neo) adjuvant endocrine therapy, such (neo) adjuvant endocrine therapy will be taken as one line of systemic therapy.
  • ECOG (Eastern Cooperative Oncology Group) performance status score at 0 or 1;
Show all 18Show fewer
  • According to RECIST 1.1, patients must have at least one measurable lesion ( for any lesion received radiotherapy or other local treatments, it may be considered as a measurable lesion if disease progression is proved by radiographic evidence after completion of treatment).
  • Note: Patients with only bone metastases must have at least one bone lesion that is predominantly osteolytic if no measurable lesion is present (for patients with no measurable lesion and only one osteolytic lesion, if prior radiotherapy to that lesion was performed, it is eligible if radiographic evidence supports disease progression of this bone lesion after radiotherapy).
  • Life expectancy for at least 12 weeks;
  • The bone marrow and organ function of the patient should be adequate:
  • Absolute neutrophil count ≥1.5×109/L;
  • Hemoglobin ≥ 90 g/L (without erythrocyte transfusion in 14 days);
  • Platelets ≥75×109/L;
  • Serum total bilirubin ≤1.5×ULN (upper limit normal), and ≤3.0×ULN for patients with Gilbert's syndrome;
  • AST (aspartate aminotransferase), ALT(alanine aminotransferase) ≤2.5×ULN; for patients with liver metastasis, both AST and ALT should be ≤5×ULN;
  • Creatinine < 1.5×ULN and creatinine clearance ≥50mL/min (Ccr=((140-age) × body weight (kg))/(72×Scr (mg/dl)) or Ccr=((140-age) × body weight (kg))/(0.818×Scr (umol/L)) Note: For females, the results should be calculated by × 0.85).
  • Willingness and ability to comply with planned visits, treatment plans, laboratory tests and other trial procedures;
  • Subject should fully understand this study and agree to sign the ICF (informed consent form).

Who cannot join

  • Patients that meet any of the following conditions shall not be included in this clinical study:
  • Prior treatment criteria:
  • Prior treatment with a CDK4/6 inhibitor;
  • Prior systemic chemotherapy for advanced breast cancer;
  • Prior radiotherapy, major surgery, immunotherapy, monoclonal antibody therapy and other systemic anti-tumor therapy within 4 weeks before initiation of study drug administration;
  • Cohort 1:
Show all 28Show fewer
  • (a) Previously received two or more lines of endocrine therapy; If relapse or metastases occur within 12 months from the treatment start during the (neo) adjuvant endocrine therapy or within 12 months after the (neo) adjuvant endocrine therapy, such (neo) adjuvant endocrine therapy will be taken as one line of systemic therapy; ii. Previously received Fulvestrant as first-line endocrine therapy for advanced breast cancer; e) Cohort 2: i. Previously treated with systemic anti-tumor therapy including endocrine therapy for advanced breast cancer; Note: Patients with disease progression after more than 12 months from the initiation or completion of the (neo) adjuvant therapy are eligible; Patients received Tamoxifen or an aromatase inhibitor within 14 days or an LHRH analogue within 28 days are eligible.
  • Patients unsuitable for endocrine therapy due to metastases to any important organ or with large tumor loads, e.g., patients judged by the investigator to be unsuitable for endocrine therapy:
  • symptomatic visceral metastases;
  • rapid disease progression or impaired visceral functions;
  • Non-visceral metastases requiring chemotherapy based on the investigator's clinical judgment;
  • Failure to recover from toxic effects of prior anti-tumor therapy (> grade 2 as defined by NCI-CTCAE version 5.0);
  • Receipt strong CYP3A inhibitors (amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, etc.) or strong CYP3A inducers (carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, etc.) within 14 days before the first dose;
  • Cardiac function and diseases that meet one of the following conditions:
  • 12-lead electrocardiogram (ECG) measurements at the study site during the screening period, with a QTcF > 470 ms based on the QTcF formula;
  • Arrhythmia with clinical significance, including but not limited to complete left bundle branch block and second-degree atrioventricular block;
  • Any risk factors prolonging the QTc interval, such as hypokalemia, inherited long QT syndrome, use of drugs that prolong the QTc interval (mainly including Class Ia, Class Ic and Class III antiarrhythmic drugs; for drugs potentially prolong the QTc interval, see https://crediblemeds.org/index.php/tools/pdfdownload? f=cql_en; e.g., haloperidol, droperidolum, chloroquine, quinidine, procainamide, disopyramide, sotalol, amiodarone, doxepin, mianserin, mexiletine, loratadine, etc.).
  • Cardiac failure congestive with New York Heart Association (NYHA) classification ≥ Class 3;
  • Difficulty in swallowing, or with an active digestive disorder, or with major GI surgery, or with 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 hypersensitivity to the study drugs Letrozole, Fulvestrant, Goserelin, or to FCN-437c or any excipients;
  • Uncontrolled CNS metastases, unless all of the following requirements are met:
  • More than 4 weeks after radiotherapy or surgery before the start of the study treatment;
  • CNS metastases are clinically stable, asymptomatic and do not require hormonal or other dehydration therapy;
  • No meningeal metastases;
  • Active infection, including patients with positive hepatitis B surface antigen (HBsAg), and HBV DNA ≥1.00×103 IU/ml; patients with positive hepatitis C virus antibody (Anti-HCV); patients infected with human immunodeficiency virus (HIV);
  • For Cohort 2 only:
  • Pregnant or lactating women; ii. For female patients of childbearing potential, disagreeing to use an effective contraceptive method, such as double barrier methods, condoms and or IUDs, during treatment and for at least 30 days after the last dose of the study treatment;
  • Any other diseases or conditions with clinical significance that investigators believe may affect the compliance with the protocol or patients' signature of ICF, such as uncontrollable diabetes, active or uncontrollable infections;

Trial locations and contacts

1 site in 1 country.

Yunjiang Liu, Doctor contact

13703297890

lyj818326@126.com

Meiqi Wang, Master contact

18633051639

maggie92320@hotmail.com

China1 site, 1 recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Yunjiang Liu, Doctor, 13703297890, lyj818326@126.com

    Meiqi Wang, Master, 18633051639, maggie92320@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Antitumor Activity, Safety, and Pharmacokinetic Profile of FCN-437c in Combination With Fulvestrant or Letrozole + Goserelin in Female Patients With ER+, HER2- Advanced Breast Cancer

This is a multicenter, open-label clinical study to evaluate the safety and antitumor activity of FCN-437c in combination with Fulvestrant for the treatment of post-menopausal female patients with ER+ and HER2- advanced breast cancer, FCN-437c in combination with Letrozole + Goserelin for the treatment of pre-menopausal female patients with ER+ and HER2- advanced breast cancer, and to evaluate the PK characteristics of the FCN-437c combination therapies.

This study is consist of two cohorts, Cohort 1: FCN-437c in combination with Fulvestrant (1st or 2nd line treatment for postmenopausal ER+, HER2-advanced breast cancer); Cohort 2: FCN-437c in combination with Letrozole + Goserelin (1st line treatment for premenopausal ER+, HER2- advanced breast cancer). Thirty patients will be enrolled in each cohort, for a total of 60 patients.

Read more

Tumor Assessment:

Tumor evaluation will be performed every 8 weeks (±7 days) according to RECIST version 1.1 until disease progression, withdrawal of informed consent, or death; for patients who discontinue the drug due to toxicity, imaging evaluation is required until disease progression.

End of Treatment and End of Study:

End of Study (EOS) is defined as 2 years after the last patient's first dose or the end of treatment (whichever is earlier). At the end of the study, the investigator will decide whether the patients whose disease has not progressed shall continue taking FCN-437c and other combination agents or not based on clinical benefit.

Cohort 1: Post-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have not received prior systemic therapy for advanced breast cancer, or who have disease progression determined by imaging assessment during their 1st line endocrine therapy; Cohort 2: Pre-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have not received prior systemic therapy for advanced breast cancer;

Read the detailed description

Screening period (Day-28 to Day-1);

  • Continuous dose treatment period: 28 days for each treatment cycle, with patients evaluated every 8 weeks until disease progression, withdrawal of informed consent or death; for patients discontinued due to toxicity, imaging evaluation is required until disease progression;
  • Follow-up after the end of treatment (within 30 days from the last dose);
  • Survival follow-up (once telephone follow-up every 3 months until the end of study);

Primary Objectives:

  • To observe the efficacy and safety of continuous oral administration of FCN-437c in combination with Fulvestrant in post-menopausal female patients with ER+, HER2- advanced breast cancer;
  • To observe the efficacy and safety of continuous oral administration of FCN-437c in combination with Letrozole + Goserelin in pre-menopausal female patients with ER+, HER2- advanced breast cancer;

Secondary Objectives:

  • To characterize the PK profile of FCN-437c in combination with Letrozole + Goserelin;
  • To characterize the PK profile of FCN-437c in combination with Fulvestrant; End of study: 2 years after the last patient's first dose or the end of treatment (whichever is earlier);
Being tested
FCN-437c+Fulvestrant, FCN-437c+Letrozole+Goserelin
Keywords
ER-Positive, HER2-Negative, Breast Neoplasms
Medical subject headings
Breast Neoplasms

What participants receive

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

  • FCN-437c+FulvestrantDrug

    FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Fulvestrant, C1D1 and C1D15 and Day 1 of each cycle, 500mg/day, intramuscularly.

  • FCN-437c+Letrozole+GoserelinDrug

    FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Letrozole 2.5 mg, QD, for continuous dosing; Goserelin 3.6 mg, subcutaneously, once every 28 days.

Study groups in NCT05004142
Study groupRoleWhat they receive
FCN-437c with FulvestrantExperimentalFCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Fulvestrant, C1D1 and C1D15 and Day 1 of each cycle, 500mg/day, intramuscularly.
Receives: Drug: FCN-437c+Fulvestrant
FCN-437c in combination with Letrozole + GoserelinExperimentalFCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Letrozole 2.5 mg, QD, for continuous dosing; Goserelin 3.6 mg, subcutaneously, once every 28 days.
Receives: Drug: FCN-437c+Letrozole+Goserelin

What is being measured

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

  1. Overall response rate

    Overall response rate (ORR) of FCN-437c in combination of fulvestrant in post-menopausal patients and letrozole + goserelin in pre-menopausal patients based on RECIST 1.1

    Measured: through study completion, assessed up to 24 months

Secondary outcomes (9)

  1. Safety and tolerability of the combination therapy

    Assessed by grade and frequency of adverse events, serious adverse events, AEs leading to permanent drug discontinuation and death and changes in lab values, vital signs, ECGs, physical examinations and ECOG status.

    Measured: Up to 30 days after EOT

  2. PFS

    Progression free survival (PFS) during the treatment.

    Measured: through study completion, assessed up to 24 months

  3. OS

    overall survival (OS) during the treatment.

    Measured: through study completion, assessed up to 24 months

  4. 1-year overall survival rate

    1-year OS rate during the treatment.

    Measured: through study completion, assessed up to 24 months

  5. DOR

    duration of response (DOR) during the treatment.

    Measured: through study completion, assessed up to 24 months

  6. CBR

    Clinical benefit response (CBR) during the treatment.

    Measured: through study completion, assessed up to 24 months

  7. PK parameters of FCN-437c combination therapy Cmax

    Plasma concentration of FCN-437c and PK parameters

    Measured: Plasma concentration of FCN-437c and PK parameters

  8. PK parameters of FCN-437c combination therapy AUC

    Plasma concentration of FCN-437c and PK parameters

    Measured: Plasma concentration of FCN-437c and PK parameters

  9. PK parameters of FCN-437c combination therapy Tmax

    Plasma concentration of FCN-437c and PK parameters

    Measured: Plasma concentration of FCN-437c and PK parameters

Timeline

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

  1. First posted13 Aug 2021
  2. Study start30 Jun 2020
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Jun 2023 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004142
Sponsor's protocol ID
AH150202-1
Status last verified
Jun 2021
First submitted
15 Jun 2021
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.

    PubMed 29860922

  • Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.

    PubMed 31166679

  • Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

    PubMed 28580882

  • Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.

    PubMed 26947331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FCN-437c+Fulvestrant and FCN-437c+Letrozole+Goserelin in people with Breast Neoplasms, 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 18 inclusion and 28 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 13 Aug 2021. 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 Yunjiang Liu, Doctor (13703297890, lyj818326@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: through study completion, assessed up to 24 months). 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 NCT05004142, which also lists 4 linked publications.

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 13 Aug 2021.

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