Trial · NCT02897700
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
NCT02897700, Phase 1, Recruiting, Shanghai Jiao Tong University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast. Trials, record NCT02897700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02897700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
- NCT number
- NCT02897700
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Conditions
- Breast Cancer
- Interventions
- Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate, cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM), Placebo
- First posted
- 2016-09-13
- Last updated
- 2024-04-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events | 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. |
| Secondary | Circulating concentrations of tumor microenvironment-specific soluble factors | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02897700
GET https://conductscience.org/api/trials/v1/NCT02897700/registered