Advanced Breast CancerPhase 3NCT05438810
This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.
A Phase 3 study testing FCN-437c,Fulvestrant,Goserelin acetate in people with Advanced Breast Cancer and Female Breast Cancer, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
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 fluvestrant ± goseraline versus placebo in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer. 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,Fulvestrant,Goserelin acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to 18 May 2024
- 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:
- Female advanced breast cancer patients aged ≥18 years, 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。
- Arbitrary menopausal status.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..
- Previous treatment criteria: Second-line and above patients can be included in the group。
- Previous treatment criteria: Second-line and above patients can be enrolled. Eastern cooperative oncology group (ECOG) 0-1。
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- 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 bone marrow and organ function:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Hemoglobin ≥90 g/dL(no red blood cell infusion within 14 days before randomization)
- Platelet count ≥90 x 109/L
- Total serum bilirubin ≤ 1.5 X upper limit of normal (ULN) , total serum bilirubin≤3 x ULN in patients with Gilbert syndrome;
- Aspartate aminotransferase (AST)and alanine aminotransferase (ALT) ≤2.5x 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 ；
- The patient is willing and able to comply with planned visits, treatment plans, laboratory examinations, and other trial procedures。
- The patient is fully aware of the study and has signed an informed consent form (ICF);
- For perimenopausal/premenopausal patients only: a high-efficiency contraceptive method with a failure rate of less than 1% per year must be used with a partner throughout the study period and for at least 90 days after discontinuation.
Who cannot join
- Patients who meet any of the following conditions are not allowed to enter this clinical study：
- The exclusion criteria for prior treatment are as follows
- Patients who received prior treatment with any CDK4/6 inhibitors or fulvestrant or everolimus;
- Received more than first-line systemic chemotherapy for advanced breast cancer.;
- Received endocrine therapy within 2 weeks prior to initial administration;
- Received radiotherapy, major surgery, tumor immunotherapy, monoclonal antitumor drug therapy, and other systemic antitumor therapies that the investigator considered would interfere with the efficacy of the investigational drug within 4 weeks prior to initial administration.
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- Patients with visceral crises who are not suitable for endocrine therapy.
- Inflammatory breast cancer.
- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to initial administration).
- 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.
- Toxic response to prior antineoplastic therapy has not recovered to ≤ grade 1 (NCI-CTCAE version 5.0).
- Cardiac function and disease conform to one of the following conditions:
- During the screening period, 12-lead Electrocardiogram (ECG) measurements are performed at the research center, calculated according to the QTcF formula using the instrument,QTcF interval >470 msec.
- Clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block.
- Any risk factors that increase QTc prolongation, such as hypokalemia, hereditary long QT syndrome, taking drugs that prolong QTc (mainly including anti-IA, Ic, and class III antiarrhythmic drugs), and drugs that potentially prolong QTc are listed in Appendix 6.
- Congestive Heart failure rated grade 2 or higher by the New York Heart Association (NYHA).
- 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 fulvestrant, Goserelin, FCN-437C or any other excipients;
- 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;
- 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).
- 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.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, M.D., 13816110335, xchu2009@hotmail.com
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 Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- 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 fluvestrant ± goseraline versus placebo in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Female Breast Cancer
- Being tested
- FCN-437c,Fulvestrant,Goserelin acetate, Placebo,Fulvestrant,Goserelin acetate
- Keywords
- HR receptor positive HER2 receptor negative, Combined with flulvestrone ± goseraline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-437c,Fulvestrant,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。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles ； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
Placebo,Fulvestrant,Goserelin acetateDrug
Placebo：available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。
| Study group | Role | What they receive |
|---|---|---|
| FCN-437c+Fulvestrant ± Goserelin acetate | Experimental | Not described Receives: Drug: FCN-437c,Fulvestrant,Goserelin acetate |
| Placebo+ Fulvestrant ± Goserelin acetate | Placebo comparator | Not described Receives: Drug: Placebo,Fulvestrant,Goserelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS is determined by the IRC
Progression-free survival is determined by the IRC according to the RECIST version 1.1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start18 Jan 2022
- Primary completion18 Feb 2024 (estimated)
- Study completion18 May 2024 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438810
- Sponsor's protocol ID
- FCN-437c-III202
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05438810
- Acronym / sponsor ID
- FCN-437c-III202
- Conditions
- Advanced Breast Cancer, Female Breast Cancer
- Keywords
- HR receptor positive HER2 receptor negative, Combined with flulvestrone ± goseraline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Feb 2024 (estimated)
- Study completion
- 18 May 2024 (estimated)
- First posted
- 30 Jun 2022 (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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase iii clinical study evaluating the efficacy and safety of FCN- 437c in combination with fluvestrant ± goseraline versus placebo in combination with fluvestrant ± goseraline in women with HR+ and HER2- advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCN-437c+Fulvestrant ± Goserelin acetate | Experimental | Drug: FCN-437c,Fulvestrant,Goserelin acetate |
| Placebo+ Fulvestrant ± Goserelin acetate | Placebo comparator | Drug: Placebo,Fulvestrant,Goserelin acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Female advanced breast cancer patients aged ≥18 years, 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。
- Arbitrary menopausal status.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..
- Previous treatment criteria: Second-line and above patients can be included in the group。
- Previous treatment criteria: Second-line and above patients can be enrolled. Eastern cooperative oncology group (ECOG) 0-1。
Key exclusion criteria (21 listed)
- Patients who meet any of the following conditions are not allowed to enter this clinical study：
- The exclusion criteria for prior treatment are as follows
- Patients with visceral crises who are not suitable for endocrine therapy.
- Inflammatory breast cancer.
- Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to initial administration).
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 |
|---|---|---|
| FCN-437c,Fulvestrant,Goserelin acetateFCN-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。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles ； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。 | Drug | FCN-437c+Fulvestrant ± Goserelin acetate |
| Placebo,Fulvestrant,Goserelin acetatePlacebo：available in 25mg and 100mg capsules, and is administered in the same way as FCN-437c。 Fulvestrant：500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 only for other cycles； Goserelin acetate：premenopausal /perimenopausal patients should be coadministered with 3.6mg, Subcutaneously at every 28 days until progressive disease。 | Drug | Placebo+ Fulvestrant ± Goserelin acetate |
Primary outcome
PFS is determined by the IRC
Time frame: 2 years
Progression-free survival is determined by the IRC according to the RECIST version 1.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Xichun Hu principal investigator
Fudan University
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 FCN-437c,Fulvestrant,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 20 inclusion and 21 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 5 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 the IRC (time frame: 2 years). 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 5 Jul 2022.