Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408408
Status:
UNKNOWN
Last Update Posted:
2017-09-18
First Post:
2006-12-06
Brief Title:
Chemotherapy With or Without Bevacizumab in Treating Women With Stage I Stage II or Stage IIIA Breast Cancer That Can Be Removed By Surgery
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response pCR of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving bevacizumab after surgery may kill any tumor cells that remain after surgery It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer
PURPOSE This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I stage II or stage IIIA breast cancer that can be removed by surgery
PURPOSE This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I stage II or stage IIIA breast cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of docetaxel followed by doxorubicin hydrocloride and cyclophosphamide AC vs docetaxel and capecitabine followed by AC vs docetaxel and gemcitabine hydrochloride followed by AC with or without bevacizumab in terms of an increase in the rate of pathologic complete response pCR in the breast in women with palpable or operable breast cancer
Secondary
Compare docetaxelcapecitabine with AC vs docetaxelgemcitabine hydrochloride with AC vs docetaxel with AC with or without bevacizumab in terms of the rate of pCR in the breast and all post-therapy lymph nodes evaluated histologically pCR breast and nodes
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens docetaxel with AC docetaxel and capecitabine with AC and docetaxel and gemcitabine hydrochloride with AC will increase the rate of pCR of the breast and nodes compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel with or without bevacizumab will increase the rate of clinical overall response cOR compared to docetaxel alone with or without bevacizumab in these patients
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens will increase the rate of cOR compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel with or without bevacizumab will increase the rate of clinical complete response cCR compared to docetaxel alone with or without bevacizumab in these patients
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens docetaxel with AC docetaxelcapecitabine with AC and docetaxelgemcitabine hydrochloride with AC will increase the rate of cCR compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Identify gene expression profiles that can predict pCR in patients treated with the different sequential docetaxelanthracycline-based regimens with or without bevacizumab
Identify gene expression profiles that can predict cOR in patients treated with docetaxel alone docetaxelcapecitabine or docetaxelgemcitabine hydrochloride with or without bevacizumab
Determine the accuracy of an in vitro chemoresponse assay ChemoFx as a predictor of pCR in patients treated with the different sequential docetaxelanthracycline-based regimens without bevacizumab
Determine the accuracy of ChemoFx as a predictor of cOR in patients treated with docetaxel alone docetaxelcapecitabine or docetaxelgemcitabine hydrochloride without bevacizumab in these patients
Determine the impact of preoperative bevacizumab and sequential chemotherapy regimens and postoperative bevacizumab therapy on cardiac function in these patients
Determine the impact of bevacizumab on surgical complications in these patients
Determine the toxicity of the preoperative regimens and the toxicity of postoperative bevacizumab in these patients
Compare the docetaxelanthracycline-based regimens with vs without bevacizumab in terms of an increase in disease-free survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor size 2-4 cm vs 4 cm nodal status negative vs positive hormone receptor status estrogen receptor ER-positive andor progesterone-receptor PgR-positive vs ER- and PgR-negative and age 50 years vs 50 years Patients are randomized to 1 of 6 treatment arms
Core needle biopsies are performed at baseline Tumor tissue samples are also collected during definitive surgery Samples are examined for gene expression and polymorphism by reverse transcriptase-polymerase chain reaction analysis and chemoresponse assay ChemoFx
After completion of study therapy patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study
Primary
Compare the efficacy of docetaxel followed by doxorubicin hydrocloride and cyclophosphamide AC vs docetaxel and capecitabine followed by AC vs docetaxel and gemcitabine hydrochloride followed by AC with or without bevacizumab in terms of an increase in the rate of pathologic complete response pCR in the breast in women with palpable or operable breast cancer
Secondary
Compare docetaxelcapecitabine with AC vs docetaxelgemcitabine hydrochloride with AC vs docetaxel with AC with or without bevacizumab in terms of the rate of pCR in the breast and all post-therapy lymph nodes evaluated histologically pCR breast and nodes
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens docetaxel with AC docetaxel and capecitabine with AC and docetaxel and gemcitabine hydrochloride with AC will increase the rate of pCR of the breast and nodes compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel with or without bevacizumab will increase the rate of clinical overall response cOR compared to docetaxel alone with or without bevacizumab in these patients
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens will increase the rate of cOR compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel with or without bevacizumab will increase the rate of clinical complete response cCR compared to docetaxel alone with or without bevacizumab in these patients
Determine whether the addition of bevacizumab to the docetaxelanthracycline-based regimens docetaxel with AC docetaxelcapecitabine with AC and docetaxelgemcitabine hydrochloride with AC will increase the rate of cCR compared to the same docetaxelanthracycline-based regimens without bevacizumab in these patients
Identify gene expression profiles that can predict pCR in patients treated with the different sequential docetaxelanthracycline-based regimens with or without bevacizumab
Identify gene expression profiles that can predict cOR in patients treated with docetaxel alone docetaxelcapecitabine or docetaxelgemcitabine hydrochloride with or without bevacizumab
Determine the accuracy of an in vitro chemoresponse assay ChemoFx as a predictor of pCR in patients treated with the different sequential docetaxelanthracycline-based regimens without bevacizumab
Determine the accuracy of ChemoFx as a predictor of cOR in patients treated with docetaxel alone docetaxelcapecitabine or docetaxelgemcitabine hydrochloride without bevacizumab in these patients
Determine the impact of preoperative bevacizumab and sequential chemotherapy regimens and postoperative bevacizumab therapy on cardiac function in these patients
Determine the impact of bevacizumab on surgical complications in these patients
Determine the toxicity of the preoperative regimens and the toxicity of postoperative bevacizumab in these patients
Compare the docetaxelanthracycline-based regimens with vs without bevacizumab in terms of an increase in disease-free survival of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor size 2-4 cm vs 4 cm nodal status negative vs positive hormone receptor status estrogen receptor ER-positive andor progesterone-receptor PgR-positive vs ER- and PgR-negative and age 50 years vs 50 years Patients are randomized to 1 of 6 treatment arms
Core needle biopsies are performed at baseline Tumor tissue samples are also collected during definitive surgery Samples are examined for gene expression and polymorphism by reverse transcriptase-polymerase chain reaction analysis and chemoresponse assay ChemoFx
After completion of study therapy patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study
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 |
|---|---|---|---|
| NSABP B-40 | None | None | None |