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The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT04131881
Recruitment Status : Completed
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients were recruited.The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

Condition or disease
Breast Cancer Drug Effect

Detailed Description:
Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients who would receive neoadjuvant chemotherapy were recruited.Breast cancer tissues were obtained before chemotherapy. The breast cancer cells were cultured in unadhesive dishes. Chemotherapy drugs were put in dishes and drug sensitivity were evaluated. Patients received operation and pathological evaluationc after neoadjuvant chemotherapy. The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Consistency of Drug Sensitivity in Vitro and Neoadjuvant Chemotherapy Results in Vivo for Early Breast Cancer Patients
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Consistency rate of drug sensitivity in vitro and in vivo [ Time Frame: through study completion, an average of 2 years ]
    Compute the percentage of patients whose drug sensitivity were consistent between in vitro and in vivo, as both were sensitive or insensitive.


Biospecimen Retention:   Samples With DNA
blood sample were retention


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in this study were invasive early breast cancer patients who were candidate for neoadjuvant chemotherapy.
Criteria

Inclusion Criteria:

  • invasive breast cancer candidates for neoadjuvant chemotherapy agreed to participate in this observative experiments could receive operation normal liver and renal function

Exclusion Criteria:

  • inflammatory breast cancer recurrent breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131881


Locations
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China, Beijing
Peking University People'S Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Peking University
Investigators
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Principal Investigator: Shu Wang, doctor Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04131881     History of Changes
Other Study ID Numbers: PKUPH10B002
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases