Breast CancerPhase 1COC-IDCBNCT02897700
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
A Phase 1 study testing Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate and cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate and cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2013to Dec 2027
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast
- no severe major organ dysfunction
- Patients must have adequate hematopoietic function as evidenced by:
- white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transfusion dependent
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal
- Individuals of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1.
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- World Health Organization (WHO) performance status of 0 or 1
- No prior or concurrent cancer-associated chemotherapy, no initiation of new hormonal therapy
- Hormone receptor (estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2)) status not specified
- Menopausal status not specified
- Patients or their legal representatives must be willing and able to provide written informed consent
- A Clinical Stage ≥ I subtype A (IA) (T1a, N0, M0) of Beast Cancer but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer-PrimaryTumor, Regional Nodes and Metastasis (TNM) staging system) as determined by a preoperative evaluation that included a chest computed tomography (CT) scan and/or X-ray mammography.
Who cannot join
- Age < 18
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
- Stage IV
- Patients with symptomatic central nervous system (CNS) metastases from breast cancer
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- Patients with a history of another invasive malignancy within the last 3 years
- History of loss of consciousness or transient ischemic attack within 12 months before study treatment initiation.
- Patients who have known active HIV, Hepatitis B, or Hepatitis C infections.
- Patients with any other condition which in the opinion of the investigator would preclude participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
China-Japan Union Hospital, Jilin University
Changchun, Jilin, 130033
Xian-Ling Cong, M.D, 86-0431-89876626, congxl888@hotmail.com
- Recruiting
Ganzhou City People's Hospital
Ganzhou, Jiangxi, 341000
Xiao-Ming Zhong, M.D, 86-18160779919, jxthrz@qq.com
- Recruiting
Shanghai 10th People's Hospital, Tongji University School of Medicine
Shanghai, 200072
Da Fu, Ph.D, 86-15921527578, fu800da900@126.com
About this study
Official title: A Phase I Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of Chemotherapeutic Regiments in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe, tolerable, and effective in the treatment of patients with infiltrating ductal carcinoma of breast.
Read the detailed description
Infiltrating ductal carcinoma (IDC) of breast, or sometimes called invasive ductal carcinoma of breast, is the most common type of breast malignancy. About 80% of all breast cancers are IDCs.
Once found, IDC usually has already broken through the wall of the milk duct and begun to invade the tissues of the breast. Over time, IDC can spread to the lymph nodes and possibly to other areas of the body with high frequency.
According to the statistics of American Cancer Society, more than 180,000 women in the United States are diagnosed with IDC each year. Although IDC can affect women at any age, it is more common as they grow older. Further, approximately two-thirds of women are 55 or older when they are diagnosed with such this symptom.
The treatments for invasive ductal carcinoma fall into two broad categories. First, local treatments for IDC, including surgery and radiation, which treat the primary tumor and surrounding areas such as the chest and lymph nodes. Second, systemic treatments for IDC, including chemotherapy, hormone therapy and targeted therapy, which are supposed to deliver cytotoxicity throughout the body to eliminate any cancer cells that have left the primary site and to help minimize the risk of recurrent disease.
PURPOSE: This randomized phase I trial is to determine the safety, tolerability and efficacy of single or concurrent administration of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) to women undergoing surgery for infiltrating ductal carcinoma in situ breast cancer.
RATIONALE: This is a randomized, controlled, open-labeled and multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms A or B). Patients accrued as control participants are assigned to arm C. to implement the study, the investigators will collect surgical samples of the primary tumor and periphery blood from breast cancer patients to assess the effects of chemotherapeutic regimens and correlation with post-therapy survival in the patient cohorts. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also analyze and evaluate the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to confirm the treatment efficacy and appraise the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
- Conditions
- Breast Cancer
- Being tested
- Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM), Placebo
- Keywords
- Chemotherapy, Safety, Tolerability, Efficacy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexateDrug
Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)Drug
Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
PlaceboDrug
Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.
| Study group | Role | What they receive |
|---|---|---|
| Mono-chemotherapy | Experimental | A mono-chemotherapy (a single chemotherapeutic agent out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (or CDEFM) was performed 30~60 days prior to surgery for patients who had no history of receiving either local or systemic cancer-associated chemotherapy.
Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate. Receives: Drug: Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate |
| Combined chemotherapy | Experimental | Combined chemotherapy (random combination of two breast cancer chemotherapeutic agents including cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, or CDEFM) was performed 30~60 days prior to surgery for patients who had no history of receiving either local or systemic chemotherapy for cancer.
Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate. Receives: Drug: cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) |
| Placebo treatment | Placebo comparator | No chemotherapeutic regimes using any cytotoxic agent was done for patients who have infiltrating ductal carcinoma of breast. Placebo was used instead. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
The case of emergent events caused by treatment is measured by counting the blood cell number and detecting liver and kidney functions. Total blood cell number, alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) > 20% above upper limit of normal, is considered as not safe.
Tolerability is measured by monitoring the first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) (NCI-CTC version 4; or CTCAE v4.0) and/or disruption of chemotherapy because of inacceptable toxicity.
Chemotherapeutic efficacy is measured by the remaining tumor size after computed tomography (CT) scanning and comparing it with the original primary tumor size 2-3 weeks after last cycle of chemotherapy. The ratio of post-treatment tumor size to pre-treatment tumor size < 50% is considered as effective. Otherwise not.
Measured: 6 months
Secondary outcomes (1)
Circulating concentrations of tumor microenvironment-specific soluble factors
Influence of the cytotoxicity of chemotherapeutic regimens on the primary tumor microenvironment is systemically measured for each patient. The circulating amounts per volume of a group of literature-reported soluble factors including interleukin (IL)-6, IL-8, granulocyte macrophage colony stimulating factor (GM-CSF), Wnt family member 16B (WNT16B) and serine peptidase inhibitor Kazal type 1 (SPINK1) are measured in the peripheral blood 2-3 weeks post treatments to assess the influence of chemotherapies. Concentration of either IL-6 > 50 ng/ml, IL-8 > 80 ng/ml, GM-CSF > 20 ng/ml, WNT16B > 100 ng/ml or SPINK1 > 60 ng/ml, is considered that the primary tumor has an activated microenvironment. The measurement continues for two more times, including one performed at 2 months and the other performed as 6 months after completion of chemotherapeutic regimens.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, China-Japan Union Hospital, Jilin University, Ganzhou City People's Hospital
- Responsible party
- Principal investigator, Yu Sun, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yu Sun, Ph.D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897700
- Sponsor's protocol ID
- BCA-81472709
- Acronym
- COC-IDCB
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2016
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Output data from this clinical study will be be made available to the public appropriately upon complete of the primary investigation, according to the original plan.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of Chemotherapeutic Regiments in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
- ClinicalTrials.gov ID
- NCT02897700
- Acronym / sponsor ID
- COC-IDCB / BCA-81472709
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy, Safety, Tolerability, Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai 10th People's Hospital, China-Japan Union Hospital, Jilin University, Ganzhou City People's Hospital
- Study start
- Jan 2013
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
The overarching purpose of this study is to determine if the mainstay chemotherapeutic regimens represented by several genotoxic agents including but not limited to Cyclophosphamide, Doxorubicin, Epirubicin, Fluorouracil and Methotrexate (CDEFM), in the format of either a single agent or combinations are safe, tolerable, and effective in the treatment of patients with infiltrating ductal carcinoma of breast.
Detailed description
Infiltrating ductal carcinoma (IDC) of breast, or sometimes called invasive ductal carcinoma of breast, is the most common type of breast malignancy. About 80% of all breast cancers are IDCs.
Once found, IDC usually has already broken through the wall of the milk duct and begun to invade the tissues of the breast. Over time, IDC can spread to the lymph nodes and possibly to other areas of the body with high frequency.
According to the statistics of American Cancer Society, more than 180,000 women in the United States are diagnosed with IDC each year. Although IDC can affect women at any age, it is more common as they grow older. Further, approximately two-thirds of women are 55 or older when they are diagnosed with such this symptom.
The treatments for invasive ductal carcinoma fall into two broad categories. First, local treatments for IDC, including surgery and radiation, which treat the primary tumor and surrounding areas such as the chest and lymph nodes. Second, systemic treatments for IDC, including chemotherapy, hormone therapy and targeted therapy, which are supposed to deliver cytotoxicity throughout the body to eliminate any cancer cells that have left the primary site and to help minimize the risk of recurrent disease.
PURPOSE: This randomized phase I trial is to determine the safety, tolerability and efficacy of single or concurrent administration of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) to women undergoing surgery for infiltrating ductal carcinoma in situ breast cancer.
RATIONALE: This is a randomized, controlled, open-labeled and multicenter, pilot study. Patients are randomized to 1 of 2 treatment arms (arms A or B). Patients accrued as control participants are assigned to arm C. to implement the study, the investigators will collect surgical samples of the primary tumor and periphery blood from breast cancer patients to assess the effects of chemotherapeutic regimens and correlation with post-therapy survival in the patient cohorts. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, the investigators also analyze and evaluate the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to confirm the treatment efficacy and appraise the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mono-chemotherapy | Experimental | Drug: Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexateA mono-chemotherapy (a single chemotherapeutic agent out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (or CDEFM) was performed 30~60 days prior to surgery for patients who had no history of receiving either local or systemic cancer-associated chemotherapy. Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate. |
| Combined chemotherapy | Experimental | Drug: cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)Combined chemotherapy (random combination of two breast cancer chemotherapeutic agents including cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, or CDEFM) was performed 30~60 days prior to surgery for patients who had no history of receiving either local or systemic chemotherapy for cancer. Interventions: cyclophosphamide, doxorubicin, epirubicin, fluorouracil or methotrexate. |
| Placebo treatment | Placebo comparator | Drug: PlaceboNo chemotherapeutic regimes using any cytotoxic agent was done for patients who have infiltrating ductal carcinoma of breast. Placebo was used instead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast
- no severe major organ dysfunction
- Patients must have adequate hematopoietic function as evidenced by:
- white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transfusion dependent
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal
Key exclusion criteria (10 listed)
- Age < 18
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
- Stage IV
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 |
|---|---|---|
| Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexateProcedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery. | Drug | Mono-chemotherapy |
| cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery. | Drug | Combined chemotherapy |
| PlaceboProcedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent. | Drug | Placebo treatment |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 6 months
The case of emergent events caused by treatment is measured by counting the blood cell number and detecting liver and kidney functions. Total blood cell number, alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) > 20% above upper limit of normal, is considered as not safe. Tolerability is measured by monitoring the first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) (NCI-CTC version 4; or CTCAE v4.0) and/or disruption of chemotherapy because of inacceptable toxicity. Chemotherapeutic efficacy is measured by the remaining tumor size after computed tomography (CT) scanning and comparing it with the original primary tumor size 2-3 weeks after last cycle of chemotherapy. The ratio of post-treatment tumor size to pre-treatment tumor size < 50% is considered as effective. Otherwise not.
1 secondary outcome
Circulating concentrations of tumor microenvironment-specific soluble factors
Time frame: 6 months
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 17 Apr 2024.
- Individual participant dataSharing planned: Yes. Output data from this clinical study will be be made available to the public appropriately upon complete of the primary investigation, according to the original plan.
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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.
Yu Sun, Ph.D principal investigator
Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate and cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 3 sites 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 10 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yu Sun, Ph.D (86-21-54923302, sunyu@sibs.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 6 months). 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 17 Apr 2024.