A Phase 1 interventional study of LX-039 tablets in Advanced Breast Cancer, sponsored by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Phase 1, Interventional, and Treatment
Among 1,928 studies in Breast Neoplasms with a site in China — 866 open to participants now, 1,064 under way, 210 of them phase 3. Breast Neoplasms · China.
Among the 1,928 studies in Breast Neoplasms with a site in China, this one is the 1,198th largest by enrollment of the 1,519 interventional ones that give a count, is one of 128 that started in 2020, is one of 171 in phase 1, and was the 525th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →866 of the 1,928 studies in Breast Neoplasms with a site in China are open now. Recruiting first, the newest first:
First Affiliated Hospital of Guangxi Medical University · Sites in China
Ages 18–70 · Women only
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Fudan University · Sites in China
Ages 18–75 · Women only
Fudan University · Sites in China
Ages 18+ · Women only
Guangdong Provincial People's Hospital · Sites in China
Ages 18–75 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,928 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 279 · Phase 2 641 · Phase 3 371 · Phase 4 51
First in 1997; this study’s year is marked. 128 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 120 across the 1,519 interventional studies, 240 across the 407 observational. Of the 444 that completed or were terminated, 77 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
488 of 1,928 have an industry lead sponsor. The 10 most frequent:
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
251 of the studies in Breast Neoplasms with a site in China that are under way reach primary completion within a year, 43 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT06954961Phase 3InventisBio Co., LtdA Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer | 2026-11-30 |
| NCT06968585Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy | 2026-11-30 |
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
Add all 251 to your calendar (.ics) → With an account.
Among the 1,928 studies in Breast Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 \~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The investigational product for this study is LX-039 tablets,which can be administered orally. 6\~8 ascending dose level until MTD and the specification included 50 mg, 100 mg, 200 mg, 400 mg, 600 mg , 800 mg,1050 mg and 1400 mg. LX-039 tablets will be administered in a therapeutic cycle of 28 days once a day orally. The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Drug: LX-039 tablets
2\~3 selected tolerable dose will be selected according to the tolerance and FES PET results of dose escalation phase.The subjects will continue therapy with LX-039 if good safety and tolerability were assessed by investigators after one cycle treatment. The treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Drug: LX-039 tablets
orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
To explore the tolerance of LX-039 in ER +, HER2 - patients with advanced breast cancer
Incidence of dose limiting toxicities (DLTs)
Time frame: DLT observation period(5 weeks for dose escalation, 4 weeks for dose expansion)
The safety of LX-039 in ER +, HER2 - patients with advanced breast cancer
Number of participants with treatment related. adverse events as assessed by CTCAE v5.0
Time frame: through study completion,an average of 1 year
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
Objective response rate (ORR)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with complete response (CR）
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with partial response (PR）
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with stable disease (SD)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
proportion of subjects with progressive disease (PD)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
duration of response (DoR)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
disease control rate (DCR)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
clinical benefit rate (CBR)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
time to progression (TTP)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
progression-free survival (PFS)
Time frame: through study completion，an average of 1 year.
To explore the efficacy of LX-039 in ER +, HER2 - patients with advanced breast cancer according to Recist 1.1.
overall survival (OS)
Time frame: through study completion，an average of 1 year.
Comparison of changes in maximum uptake ability of FES(progression free survival) in breast cancer lesions before and after treatment with LX-039 by PET(positron emission tomography) scan (performed in some subjects)
Decrease in SUVmax in comparison with that before treatment
Time frame: Up to the third day of Cycle 2(each cycle is 28 days)
PK profiles after a single dose of LX-039
Peak Concentration (Cmax)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Peak Time (Tmax)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Elimination Half-life (t1/2)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Eliminate Rate Constant (Kel)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Mean Residence Time (MRT)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from 0 time to 24 hours (AUC0-24h)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from 0 time to sampling time t of the last measurable concentration (AUC0-last)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Area under plasma Concentration-time curve from administration (0) to infinity (AUC0-inf)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Apparent Total Clearance (CL/F)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after a single dose of LX-039
Apparent Volume of Distribution (Vd/F)
Time frame: Up to the third day of Cycle 0(Cycle 0 is 7 days)
PK profiles after continuous administration of LX-039
Trough Concentration at Steady State (Css, min)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Peak Concentration at Steady State (Css, max)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Average Concentration at Steady State (Css, av)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Peak Time (Tss, max)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Apparent Volume of Distribution at steady state (Vss/F)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Steady-state Clearance Half-life (tss,1/2)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Total Body Clearance (CLss/F)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Coefficient of Fluctuation (DF)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Area under Plasma Concentration-time Curve at Steady State (AUCss)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
PK profiles after continuous administration of LX-039
Accumulation Coefficient (Rac)
Time frame: Up to the Second day of Cycle 2(each cycle is 28 days)
Ran from Jan 2020 to primary completion in Aug 2022, 31 months.
Of 388 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's 31 months is below that.
Counting every sponsor, half of 759 studies reached it within 44 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.