HER2-negative Breast CancerPhase 2ORIENTANCT06102824
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
A Phase 2 study testing Organoid-guided treatment, Taxane and Capecitabine in people with HER2-negative Breast Cancer and Advanced Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HER2-negative Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Organoid-guided treatment, Taxane and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be competent and able to comprehend, sign, and date a written informed consent form (ICF) before performance of any study-specific procedures or tests.
- Men or women ≥18 years old.
- Pathologically documented unresectable locally advanced or metastatic breast cancer that:
- 3.1 Confirmed as HER2-negative status, defined as IHC 0, IHC 1+, or IHC 2+/ISH- according to American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) guidelines evaluated at a local laboratory.
- 3.2 Is HR-positive or HR-negative. Positive for estrogen receptor or progesterone receptor if a finding of ≥1% of tumor cell nuclei is immunoreactive according to ASCO/CAP guidelines.
- 3.3 Has been treated with at least 1 prior line of systemic therapy in the advanced or metastatic setting. If >10% ER expression, the subject should have been treated with a CDK4/6 inhibitor. If recurrence occurred within 6 months of adjuvant chemotherapy, adjuvant therapy would count as 1 line of systemic therapy. If recurrence occurred within 12 months of adjuvant CDK4/6 inhibitor and endocrine therapy, adjuvant therapy would count as 1 line of systemic therapy.
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- Documented radiologic progression (during or after most recent treatment).
- Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- All subjects must have a recent tumor sample after the most recent treatment regimen or agree to undergo a tissue biopsy prior to randomization.
- No visceral crisis.
- Life expectancy of ≥ 6 months as assessed by the treating investigator.
- Complete all required baseline laboratory tests and imaging examinations within 28 days before randomization.
- Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
- Male and female subjects of reproductive/childbearing potential must have a documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control (non-hormonal) during and up to 6 months after trial therapy.
- Subjects must satisfy all of the following additional criteria to be included in the OGT group:
- No absolute contraindication for invasive procedures to obtain samples for organoid generation.
- Sufficient material for organoid generation: biopsied samples (length>1cm, 2-3 pieces), surgically resected samples (>1cm×1cm×0.5cm, weight>200mg), malignant effusion samples collected by thoracentesis, abdominocentesis or lumbar puncture (pleural fluid>50mL, ascites>50mL, cerebrospinal fluid≥4 tubes with each tube ≥4mL).
- Successful acquisition of a solid tumor biopsy sample containing ≥ 20% tumor content, or malignant effusion sample (e.g., pleural, or pericardial effusion or ascites) confirmed to contain malignant cells.
Who cannot join
- Ineligible for all 5 of the study treatments either because of previously having received treatment in the advanced or metastatic setting or having a contraindication to treatment.
- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- Known active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of trial treatment and have not required high-dose steroid treatment in the last 4 weeks).
- Inflammatory breast cancer.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
- Major surgery within 3 weeks of starting study treatment: patients must have recovered from any effects of any major surgery.
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- Systemic treatment with anticancer therapy, antibody-based therapy, hormonal therapy, or radiotherapy within 3 weeks before study treatment.
- Participation in a therapeutic clinical study within 3 weeks before study treatment, or current participation in other investigational procedures.
- Has multiple primary malignancies within 3 years, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or contralateral breast cancer.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
- Substance abuse or medical conditions such as clinically significant cardiac or pulmonary diseases or psychological conditions, that would, in the opinion of the Investigator, increase the safety risk to the subject or interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
- Has known human immunodeficiency virus infection or active hepatitis B or C infection.
- Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Has gastrointestinal disorders likely to interfere with absorption of the study medication.
- Is pregnant or breastfeeding or planning to become pregnant.
- Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong-Fei Gao, M.D. contact
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Kun Wang, M.D., 02083827812, wangkun@gdph.org.cn
About this study
Official title: Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial
This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
Read the detailed description
Treatment for advanced-stage breast cancer has long been challenging. Genomic-based precision medicine was able to facilitate treatment selection in some patients, but there were considerable instances where genomic profiling failed to assign effective interventions or patients exhibited refractoriness to the drugs nominated by genomic alterations. Patient-derived organoids (PDOs) represent a tractable tool that may compensate for the drawbacks of genomic medicine to identify therapeutic opportunities in rare or metastatic cancers. Previous research has demonstrated that PDOs displayed strong biological fidelity to their original tumors and functional precision medicine based on PDO drug screening could confer survival benefits in breast cancer patients.
This multicenter, open-label, randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment (OGT) versus treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening, and subjects in the TPC group will receive treatment selected by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines. Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening. This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care.
- Being tested
- Organoid-guided treatment, Taxane, Capecitabine, Gemcitabine, Vinorelbine
- Keywords
- HER2-negative, Advanced breast cancer, Patient-derived organoids, Precision medicine, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid-guided treatmentDrug
The drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
TaxaneDrug
Also called Abraxane, Lipusu
Albumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w
CapecitabineDrug
Also called Xeloda
1000-1250mg/m2, PO, bid, days1-14, q3w
GemcitabineDrug
Also called Gemzar
800-1200mg/m2, IV, days 1, 8, q3w
VinorelbineDrug
Also called Navelbine
20-35mg/m2, IV, days 1 and 8, q3w
EribulinDrug
Also called Halaven
1.4mg/m2, IV, days 1 and 8, q3w
AnthracyclineDrug
Also called Doxil, Lipodox
Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w
CarboplatinDrug
Also called Paraplatin
Carboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w
UtideloneDrug
Also called UTD1
30mg/m2, IV, once per day on days 1-5, q3w
Trastuzumab deruxtecanDrug
Also called Enhertu
5.4mg/kg, IV, q3w
Sacituzumab govitecanDrug
Also called Trodelvy
10mg/kg, IV, days 1 and 8, q3w
| Study group | Role | What they receive |
|---|---|---|
| Organoid-guided treatment | Experimental | Subjects randomized to the organoid-guided treatment (OGT) group will be treated with the drugs predicted to be the most sensitive through PDO drug sensitivity screening. Drugs that the subjects have progressed on before randomization will not be screened. The drugs selected for organoid screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients). Receives: Drug: Organoid-guided treatment |
| Treatment of physician's choice | Active comparator | Subjects randomized to the treatment of physician's choice (TPC) group will receive physician-chosen therapy from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients). Receives: Drug: Taxane; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Eribulin; Drug: Anthracycline; Drug: Carboplatin; Drug: Utidelone; Drug: Trastuzumab deruxtecan; Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS is defined as the time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression according to RECIST version 1.1 or death due to any cause. Subjects who are alive with no objective documentation of (radiographic) disease progression by the data cutoff date for PFS analysis will be censored at the date of their last evaluable tumor assessment. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Through study completion, with an expected average of 1 year
Secondary outcomes (7)
Overall survival
OS is defined as the time from the date of randomization to the date of death for any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.
Measured: Through study completion, with an expected average of 2 year
Objective response rate
ORR is defined as the sum of complete response (CR) rate and partial response (PR) rate according to RECIST version 1.1. CR is defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR is defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Through study completion, with an expected average of 1 year
Disease control rate
DCR is defined as the sum of CR rate, PR rate, and stable disease (SD) rate. SD is defined as neither sufficient shrinkage to qualify for PR (taking as reference the sum of diameters at baseline) nor sufficient increase to qualify for PD (taking as reference the smallest sum of diameters while on study).
Measured: Through study completion, with an expected average of 1 year
Clinical benefit rate
CBR is defined as the sum of CR rate, PR rate, and more than 6 months' SD rate.
Measured: Through study completion, with an expected average of 1 year
Duration of response
DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression, or death. DoR will be measured for responding subjects (PR or CR) only. Subjects who are progression-free at the time of the analyses will be censored at the date of the last evaluable tumor assessment.
Measured: Through study completion, with an expected average of 1 year
Time to response
TTR is defined as the time from the date of randomization to the date of the first documentation of objective response (CR or PR). TTR will be measured for responding subjects (CR or PR) only.
Measured: Through study completion, with an expected average of 1 year
Adverse events
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Through study completion, with an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102824
- Sponsor's protocol ID
- 20231028
- Acronym
- ORIENTA
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06102824
- Acronym / sponsor ID
- ORIENTA / 20231028
- Keywords
- HER2-negative, Advanced breast cancer, Patient-derived organoids, Precision medicine, Randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Oct 2023 (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 phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.
Detailed description
Treatment for advanced-stage breast cancer has long been challenging. Genomic-based precision medicine was able to facilitate treatment selection in some patients, but there were considerable instances where genomic profiling failed to assign effective interventions or patients exhibited refractoriness to the drugs nominated by genomic alterations. Patient-derived organoids (PDOs) represent a tractable tool that may compensate for the drawbacks of genomic medicine to identify therapeutic opportunities in rare or metastatic cancers. Previous research has demonstrated that PDOs displayed strong biological fidelity to their original tumors and functional precision medicine based on PDO drug screening could confer survival benefits in breast cancer patients.
This multicenter, open-label, randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment (OGT) versus treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening, and subjects in the TPC group will receive treatment selected by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines. Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening. This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organoid-guided treatment | Experimental | Drug: Organoid-guided treatmentSubjects randomized to the organoid-guided treatment (OGT) group will be treated with the drugs predicted to be the most sensitive through PDO drug sensitivity screening. Drugs that the subjects have progressed on before randomization will not be screened. The drugs selected for organoid screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients). |
| Treatment of physician's choice | Active comparator | Drug: Taxane, Drug: Capecitabine, Drug: Gemcitabine, Drug: Vinorelbine, Drug: Eribulin, Drug: Anthracycline, Drug: Carboplatin, Drug: Utidelone, Drug: Trastuzumab deruxtecan, Drug: Sacituzumab govitecanSubjects randomized to the treatment of physician's choice (TPC) group will receive physician-chosen therapy from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Must be competent and able to comprehend, sign, and date a written informed consent form (ICF) before performance of any study-specific procedures or tests.
- Men or women ≥18 years old.
- Pathologically documented unresectable locally advanced or metastatic breast cancer that:
- 3.1 Confirmed as HER2-negative status, defined as IHC 0, IHC 1+, or IHC 2+/ISH- according to American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) guidelines evaluated at a local laboratory.
- 3.2 Is HR-positive or HR-negative. Positive for estrogen receptor or progesterone receptor if a finding of ≥1% of tumor cell nuclei is immunoreactive according to ASCO/CAP guidelines.
Key exclusion criteria (16 listed)
- Ineligible for all 5 of the study treatments either because of previously having received treatment in the advanced or metastatic setting or having a contraindication to treatment.
- Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- Known active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of trial treatment and have not required high-dose steroid treatment in the last 4 weeks).
- Inflammatory breast cancer.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
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 |
|---|---|---|
| Organoid-guided treatmentThe drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients). | Drug | Organoid-guided treatment |
| TaxaneAlso: Abraxane, LipusuAlbumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w | Drug | Treatment of physician's choice |
| CapecitabineAlso: Xeloda1000-1250mg/m2, PO, bid, days1-14, q3w | Drug | Treatment of physician's choice |
| GemcitabineAlso: Gemzar800-1200mg/m2, IV, days 1, 8, q3w | Drug | Treatment of physician's choice |
| VinorelbineAlso: Navelbine20-35mg/m2, IV, days 1 and 8, q3w | Drug | Treatment of physician's choice |
| EribulinAlso: Halaven1.4mg/m2, IV, days 1 and 8, q3w | Drug | Treatment of physician's choice |
| AnthracyclineAlso: Doxil, LipodoxLiposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w | Drug | Treatment of physician's choice |
| CarboplatinAlso: ParaplatinCarboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w | Drug | Treatment of physician's choice |
| UtideloneAlso: UTD130mg/m2, IV, once per day on days 1-5, q3w | Drug | Treatment of physician's choice |
| Trastuzumab deruxtecanAlso: Enhertu5.4mg/kg, IV, q3w | Drug | Treatment of physician's choice |
| Sacituzumab govitecanAlso: Trodelvy10mg/kg, IV, days 1 and 8, q3w | Drug | Treatment of physician's choice |
Primary outcome
Progression-free survival
Time frame: Through study completion, with an expected average of 1 year
PFS is defined as the time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression according to RECIST version 1.1 or death due to any cause. Subjects who are alive with no objective documentation of (radiographic) disease progression by the data cutoff date for PFS analysis will be censored at the date of their last evaluable tumor assessment. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
7 secondary outcomes
Overall survival
Time frame: Through study completion, with an expected average of 2 year
Objective response rate
Time frame: Through study completion, with an expected average of 1 year
Disease control rate
Time frame: Through study completion, with an expected average of 1 year
Clinical benefit rate
Time frame: Through study completion, with an expected average of 1 year
Duration of response
Time frame: Through study completion, with an expected average of 1 year
Time to response
Time frame: Through study completion, with an expected average of 1 year
Adverse events
Time frame: Through study completion, with an expected average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Hong-Fei Gao, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Organoid-guided treatment, Taxane and Capecitabine in people with HER2-negative Breast Cancer and Advanced Breast Cancer, run by Guangdong Provincial People's Hospital 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 19 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang, M.D. (00862083827812 ext. 50910, wangkun@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Through study completion, with an expected average of 1 year). 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 25 Nov 2024.