Triple Negative Breast CancerPhase 2NCT04745975
Guided Treatment Based on Mini-PDX in Metastatic Triple Negative Breast Cancer
A Phase 2 study testing Personalized treatment guided by mini-PDX and RNA sequencing, Nab paclitaxel and Eribulin in people with Triple Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Triple-negative breast cancer constitutes 15-20% of cases of breast cancer and is defined by the absence of estrogen receptors, progesterone receptors, and overexpression or gene amplification of HER2. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Personalized treatment guided by mini-PDX and RNA sequencing, Nab paclitaxel and Eribulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Jan 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Women aged 18-70 years;
- 2) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 3) Estimated lifetime is ≥ 3 months;
- 4) Histopathologically confirmed recurrent (unresectable) or metastatic triple-negative breast cancer; ER and PR negative is defined as ER <1% positive, PR <1% positive. HER-2 negative is defined as HER-2 (-) or (1+) by immunohistochemistry, HER-2 (2+) must be tested by FISH with negative result, HER-2 (1+) (1+), FISH is optional and negative;
- 5) Have at least one measurable target lesion according to RECIST 1.1 criteria;
- 6) Biopsy of the tumor lesion and the specimen passes laboratory quality control;
Show all 12Show fewer
- 7) A minimum of 2 prior cytotoxic chemotherapy regimens (including at least one line of platinum-containing regimen) in metastatic settings are required prior to enrollment in this trial;
- 8) Adequate organ function, i.e. meeting the following criteria.
- Hb ≥ 90 g/L (no transfusion within 14 days); ANC ≥ 1.5 × 109 /L; PLT ≥ 75 × 109 /L.
- Liver function: total bilirubin TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN.
- serum Cr ≤ 1.5×ULN.
- 9) Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
Who cannot join
- 1）Pregnancy or lactation；
- 2）History of autoimmune disease；
- 3）Anticancer- and radiation therapy-related toxicities have not resolved or downgraded to Grade 1 or less;
- 4) Symptomatic central nervous system (CNS) disease;
- 5) Previous treatment of Immune checkpoint inhibitors;
- 6) History of other malignancies within the past five years, with the exception of cured non-malignant melanoma of the skin and carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, M.D., 021-54561523, syner2000@163.com
About this study
Official title: GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION)：a Prospective Randomized Controlled Single Center Clinical Trial
Triple-negative breast cancer constitutes 15-20% of cases of breast cancer and is defined by the absence of estrogen receptors, progesterone receptors, and overexpression or gene amplification of HER2. Although the addition of immune checkpoint inhibitors could improve the outcome of patients with metastatic triple-negative breast cancer (mTNBC), chemotherapy has been the standard of care for systemic treatment for patients with mTNBC. Prognoses remain poor, with reported median overall survival estimates of approximately 18 months or less with available treatments. A meta-analysis of seven clinical trials showed that the median objective response rate (ORR) of second or later line of chemotherapy in mTNBC was only 11%.
Patient-derived xenograft (PDX) tumor model, which preserves the histologic and genetic characteristics of patients' tumors, has shown its predictive value of clinical outcomes and are used for preclinical drug evaluation, biomarker identification, biological studies, and personalized medicine strategies. However, long time period and low success rate has limited its application in clinical practice.
Read more
Mini patient derived xenograft (miniPDX) offers an effective alternative as it only takes about 7 days for drug sensitivity test and could thus provide guidance for prompt personalized treatment for each patient.
Thus, the investigators conduct this single-center, prospective, randomized controlled clinical study to investigate the efficacy of guided treatment based on Mini-PDX in patients with metastatic refractory triple negative breast cancer.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Personalized treatment guided by mini-PDX and RNA sequencing, Nab paclitaxel, Eribulin, Vinorelbine, Gemcitabine
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized treatment guided by mini-PDX and RNA sequencingDrug
Personalized treatment guided by mini-PDX and RNA sequencing
Nab paclitaxelDrug
Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8, 15, q4w
EribulinDrug
Eribulin 1.4 mg/m2, d1,8 q3w
VinorelbineDrug
Vinorelbine 25mg/m2 d1,8, q3w
GemcitabineDrug
Gemcitabine 1000 mg/m2, d1,8, q3w
CapecitabineDrug
Capecitabine 1250 mg/m2 bid po
| Study group | Role | What they receive |
|---|---|---|
| Personalized treatment guided by Mini-PDX | Experimental | The tumor tissue is used for drug sensitivity test by Mini-PDX, and acquiring the genetic information by RNA-sequence. Patients with mTNBC will receive personalized treatment guided by the experimental results of mini-PDX and RNA sequencing. Receives: Drug: Personalized treatment guided by mini-PDX and RNA sequencing |
| Treatment of Physician's Choice (TPC) | Active comparator | TPC will be administered per standard of care. Patients randomized to TPC will receive chemotherapy, including but not limited to the following agents: nab-paclitaxel, eribulin, vinorelbine, gemcitabine, capecitabine. Receives: Drug: Nab paclitaxel; Drug: Eribulin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To compare the Objective Response Rate (ORR) of patients who recieve persionalized treatment based on mini-PDX model with ORR of patients who receive Treatment of Physician's Choice (TPC). ORR is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. ORR will be calculated based on the Investigator assessment of response. CR = 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 = 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, an expected average of 1 year
Secondary outcomes (3)
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.
Measured: Through study completion, an expected average of 1 year
Progression-Free Survival
Progression-free survival is defined as the time from the date of randomization to the first evidence of documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. 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. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Measured: Through study completion, an expected average of 1 year
Adverse events
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Measured: Through study completion, 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 posted9 Feb 2021
- Study start1 Feb 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745975
- Sponsor's protocol ID
- GUMPTION
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION)：a Prospective Randomized Controlled Single Center Clinical Trial
- ClinicalTrials.gov ID
- NCT04745975
- Acronym / sponsor ID
- GUMPTION
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 9 Feb 2021 (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.
Triple-negative breast cancer constitutes 15-20% of cases of breast cancer and is defined by the absence of estrogen receptors, progesterone receptors, and overexpression or gene amplification of HER2. Although the addition of immune checkpoint inhibitors could improve the outcome of patients with metastatic triple-negative breast cancer (mTNBC), chemotherapy has been the standard of care for systemic treatment for patients with mTNBC. Prognoses remain poor, with reported median overall survival estimates of approximately 18 months or less with available treatments. A meta-analysis of seven clinical trials showed that the median objective response rate (ORR) of second or later line of chemotherapy in mTNBC was only 11%.
Patient-derived xenograft (PDX) tumor model, which preserves the histologic and genetic characteristics of patients' tumors, has shown its predictive value of clinical outcomes and are used for preclinical drug evaluation, biomarker identification, biological studies, and personalized medicine strategies. However, long time period and low success rate has limited its application in clinical practice.
Mini patient derived xenograft (miniPDX) offers an effective alternative as it only takes about 7 days for drug sensitivity test and could thus provide guidance for prompt personalized treatment for each patient.
Thus, the investigators conduct this single-center, prospective, randomized controlled clinical study to investigate the efficacy of guided treatment based on Mini-PDX in patients with metastatic refractory triple negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized treatment guided by Mini-PDX | Experimental | Drug: Personalized treatment guided by mini-PDX and RNA sequencingThe tumor tissue is used for drug sensitivity test by Mini-PDX, and acquiring the genetic information by RNA-sequence. Patients with mTNBC will receive personalized treatment guided by the experimental results of mini-PDX and RNA sequencing. |
| Treatment of Physician's Choice (TPC) | Active comparator | Drug: Nab paclitaxel, Drug: Eribulin, Drug: Vinorelbine, Drug: Gemcitabine, Drug: CapecitabineTPC will be administered per standard of care. Patients randomized to TPC will receive chemotherapy, including but not limited to the following agents: nab-paclitaxel, eribulin, vinorelbine, gemcitabine, capecitabine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1) Women aged 18-70 years;
- 2) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 3) Estimated lifetime is ≥ 3 months;
- 4) Histopathologically confirmed recurrent (unresectable) or metastatic triple-negative breast cancer; ER and PR negative is defined as ER <1% positive, PR <1% positive. HER-2 negative is defined as HER-2 (-) or (1+) by immunohistochemistry, HER-2 (2+) must be tested by FISH with negative result, HER-2 (1+) (1+), FISH is optional and negative;
- 5) Have at least one measurable target lesion according to RECIST 1.1 criteria;
Key exclusion criteria (6 listed)
- 1）Pregnancy or lactation；
- 2）History of autoimmune disease；
- 3）Anticancer- and radiation therapy-related toxicities have not resolved or downgraded to Grade 1 or less;
- 4) Symptomatic central nervous system (CNS) disease;
- 5) Previous treatment of Immune checkpoint inhibitors;
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 |
|---|---|---|
| Personalized treatment guided by mini-PDX and RNA sequencingPersonalized treatment guided by mini-PDX and RNA sequencing | Drug | Personalized treatment guided by Mini-PDX |
| Nab paclitaxelNab-paclitaxel 125 mg/m2，ivgtt，d1, 8, 15, q4w | Drug | Treatment of Physician's Choice (TPC) |
| EribulinEribulin 1.4 mg/m2, d1,8 q3w | Drug | Treatment of Physician's Choice (TPC) |
| VinorelbineVinorelbine 25mg/m2 d1,8, q3w | Drug | Treatment of Physician's Choice (TPC) |
| GemcitabineGemcitabine 1000 mg/m2, d1,8, q3w | Drug | Treatment of Physician's Choice (TPC) |
| CapecitabineCapecitabine 1250 mg/m2 bid po | Drug | Treatment of Physician's Choice (TPC) |
Primary outcome
Objective response rate
Time frame: Through study completion, an expected average of 1 year
To compare the Objective Response Rate (ORR) of patients who recieve persionalized treatment based on mini-PDX model with ORR of patients who receive Treatment of Physician's Choice (TPC). ORR is defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST 1.1. ORR will be calculated based on the Investigator assessment of response. CR = 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 = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
3 secondary outcomes
Overall Survival
Time frame: Through study completion, an expected average of 1 year
Progression-Free Survival
Time frame: Through study completion, an expected average of 1 year
Adverse events
Time frame: Through study completion, an expected average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Triple Negative Breast Cancer
Active, not recruitingPhase 3
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
Estrogen Receptor Negative, HER2/Neu Negative
RecruitingPhase 1/2
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
Metastatic Triple-Negative Breast Carcinoma
Active, not recruitingPhase 1
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Advanced Cancer, Advanced Malignancies
RecruitingEarly Phase 1
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
PDL1 Gene Mutation, Non Small Cell Lung Cancer
RecruitingPhase 1
Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype
Multiple Myeloma, Triple Negative Breast Cancer
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, M.D. 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 2 study testing Personalized treatment guided by mini-PDX and RNA sequencing, Nab paclitaxel and Eribulin in people with Triple Negative Breast Cancer, run by Fudan University 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 12 inclusion and 6 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 20 Apr 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. 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 Xichun Hu, M.D. (021-54561523, xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Through study completion, 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 20 Apr 2022.