Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328387
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-17
Brief Title:
HCQADC vs ADC in the Treatment of Advanced Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Open Controlled Multicenter Phase III Clinical Study of Hydroxychloroquine in Combination With Antibody-drug Conjugate Versus Antibody-drug Conjugate for Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Advanced breast cancer is a special subtype of human breast cancer Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients However the choice of treatment for these patients after treatment progress is a research hotspot in this field Trastuzumab Deruxtecan T-DXd and Sacituzumab Govitecan SG are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment The autophagy agents hydroxychloroquine or chloroquine has become the only FDA Food and Drug Administration approved autophagy inhibitor and hydroxychloroquine and antibody-drug conjugateADC may have synergistic effects based on the previous work results of our research group
Thereforewe envisage that Trastuzumab DeruxtecanT-DXd or Sacituzumab Govitecan SG combined with hydroxychloroquineHCQ in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival
To this end we intend to conduct a prospectivemulti-center phase III clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer
Thereforewe envisage that Trastuzumab DeruxtecanT-DXd or Sacituzumab Govitecan SG combined with hydroxychloroquineHCQ in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival
To this end we intend to conduct a prospectivemulti-center phase III clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer
Detailed Description:
Breast cancer is the most prevalent malignant tumor in the world and 30 of breast cancer patients will enter the advanced stage due to treatment failure Most patients with advanced breast cancer have had distant organ metastasis and the median progression free survival period is only 1-2 years
In the past advanced breast cancer patients faced the dilemma of poor survival due to the lack of precise targeted therapy However through a series of clinical studies experts in the field of advanced breast cancer have successfully expanded the indications of ADC-based combination targeted therapy from the emergence of first generation ADC to the third generation ADC with bystander effect which has significantly prolonged the survival time of patients Trastuzumab Deruxtecan T-DXd and Sacituzumab Govitecan SG are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment
Because both ADC and autophagy involve lysosomes and the relationship between ADC and autophagy microenvironment has not been elucidated the combination of autophagy regulators and ADC may be a treatment option that can benefit some patients moreThe autophagy agents hydroxychloroquine or chloroquine has become the only FDA Food and Drug Administration approved autophagy inhibitor And the synergistic effect of hydroxychloroquine and antibody-drug conjugate ADC has already been confirmed based on preliminary experiments of our research group We envisage that Trastuzumab Deruxtecan T-DXd or Sacituzumab Govitecan SG combined with hydroxychloroquineHCQ in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival
Therefore we intend to further validate the efficacy and safety of the Autophagy inhibitor hydroxychloroquineHCQ in combination with the latest ADC drugs T-DXd or SG in a Phase III randomized controlled clinical study in order to provide advanced breast cancer patients with a better choice of precision targeted therapy
In the past advanced breast cancer patients faced the dilemma of poor survival due to the lack of precise targeted therapy However through a series of clinical studies experts in the field of advanced breast cancer have successfully expanded the indications of ADC-based combination targeted therapy from the emergence of first generation ADC to the third generation ADC with bystander effect which has significantly prolonged the survival time of patients Trastuzumab Deruxtecan T-DXd and Sacituzumab Govitecan SG are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment
Because both ADC and autophagy involve lysosomes and the relationship between ADC and autophagy microenvironment has not been elucidated the combination of autophagy regulators and ADC may be a treatment option that can benefit some patients moreThe autophagy agents hydroxychloroquine or chloroquine has become the only FDA Food and Drug Administration approved autophagy inhibitor And the synergistic effect of hydroxychloroquine and antibody-drug conjugate ADC has already been confirmed based on preliminary experiments of our research group We envisage that Trastuzumab Deruxtecan T-DXd or Sacituzumab Govitecan SG combined with hydroxychloroquineHCQ in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival
Therefore we intend to further validate the efficacy and safety of the Autophagy inhibitor hydroxychloroquineHCQ in combination with the latest ADC drugs T-DXd or SG in a Phase III randomized controlled clinical study in order to provide advanced breast cancer patients with a better choice of precision targeted therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None