Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437359
Status:
TERMINATED
Last Update Posted:
2012-03-30
First Post:
2007-02-18
Brief Title:
Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer
Sponsor:
Japan Breast Cancer Research Network
Organization:
Japan Breast Cancer Research Network
Study Overview
Official Title:
Antiestrogen vs Aromatase Inhibitor After Chemotherapy for Adjuvant Setting Efficacy of Endocrine Therapy After Chemotherapy in Postoperative Adjuvant Therapy for Breast Cancer
Status:
TERMINATED
Status Verified Date:
2012-03
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:
To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone toremifene citrate TOR or anastrozole ANA after chemotherapy in breast cancer
Detailed Description:
To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone toremifene citrate TOR or anastrozole ANA after chemotherapy in breast cancer
TOR is reported to be as effective or more effective than TAM on both DFS and OS for postoperative adjuvant therapy The incidence rate and severity of its adverse effects are similar to those of TAM as shown in two clinical trials the Finnish Breast Cancer Group FBCG and the International Breast Cancer Study Group IBCSG Although no significant difference was observed in these trials other studies report that TOR produced a lower number of thromboembolism events compared with TAM a undesirable side effect seen in patients treated with TAM Additionally compared with TAM TOR showed less endometrial hypertrophy which is induced by estrogen
Endometrial cancer remains one of the significant problems associated with TAM A TAM metabolite binds to DNA and forms DNA adducts which damage cells It is reported that TAM has an expanded ability to form DNA adducts compared with TOR in vitro A recent study compared endometrial cells collected from patients in which TAM or TOR had been administered The k-ras gene mutation was investigated in these cases and it showed that TAM held a higher frequency of gene mutation Although we still need to discuss whether or not k-ras mutation is directly related to the development of endometrial cancer TAM seems to have a higher risk of inducing cancer compared with TOR
In the IBCSG14-93 trials two chemotherapy protocols were studied subsequent to administration of TOR They were doxorubicin and cyclophosphamide AC and cyclophosphamide methotrexate and 5-fluorouracil CMF These two chemotherapy protocols were administered in the following sequence AC four times followed by CMF three times after administration of TOR The findings revealed that in estrogen-receptor ER positive cases DFS equaled 73 in the TOR group 65 in the TAM group hormone receptor HR080 057-111 P018 OS was found to total 88 in the TOR group 84 in the TAM group HR078 048-127 p032 Although there was no significant difference in two groups the TOR group has showed somewhat improved survival
Based on the information provided above we consider TAM and TOR to have similar efficacy with less adverse effects and this trial will compare the two drugs TOR and ANA
TOR is reported to be as effective or more effective than TAM on both DFS and OS for postoperative adjuvant therapy The incidence rate and severity of its adverse effects are similar to those of TAM as shown in two clinical trials the Finnish Breast Cancer Group FBCG and the International Breast Cancer Study Group IBCSG Although no significant difference was observed in these trials other studies report that TOR produced a lower number of thromboembolism events compared with TAM a undesirable side effect seen in patients treated with TAM Additionally compared with TAM TOR showed less endometrial hypertrophy which is induced by estrogen
Endometrial cancer remains one of the significant problems associated with TAM A TAM metabolite binds to DNA and forms DNA adducts which damage cells It is reported that TAM has an expanded ability to form DNA adducts compared with TOR in vitro A recent study compared endometrial cells collected from patients in which TAM or TOR had been administered The k-ras gene mutation was investigated in these cases and it showed that TAM held a higher frequency of gene mutation Although we still need to discuss whether or not k-ras mutation is directly related to the development of endometrial cancer TAM seems to have a higher risk of inducing cancer compared with TOR
In the IBCSG14-93 trials two chemotherapy protocols were studied subsequent to administration of TOR They were doxorubicin and cyclophosphamide AC and cyclophosphamide methotrexate and 5-fluorouracil CMF These two chemotherapy protocols were administered in the following sequence AC four times followed by CMF three times after administration of TOR The findings revealed that in estrogen-receptor ER positive cases DFS equaled 73 in the TOR group 65 in the TAM group hormone receptor HR080 057-111 P018 OS was found to total 88 in the TOR group 84 in the TAM group HR078 048-127 p032 Although there was no significant difference in two groups the TOR group has showed somewhat improved survival
Based on the information provided above we consider TAM and TOR to have similar efficacy with less adverse effects and this trial will compare the two drugs TOR and ANA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMIN000000610 | None | None | None |