"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy… (NCT01641406) | Clinical Trial Compass
UnknownPhase 2
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
Puerto Rico60 participantsStarted 2011-03
Plain-language summary
The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer.
* Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible.
* Age≥ 18 years
* Only female patients are eligible
* Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is \<1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by RECIST criteria, we will nevertheless include tumors≥1cm since the primary endpoint is pathological CR rate.
* Performance status ECOG≤2 or Karnofsky≥ 50%
* Peripheral neuropathy≤ grade 1
* Hematologic (minimal values):Absolute Neutrophil count≥1,500/mm³; Hemoglobin≥8.0g/dl; Paltelet count≥100,000/mm³
* Hepatic; Total bilirubin≤ULN AST and ALT and ALP do not have to be within the range. In determining eligibility the more abnormal of the two values(AST or ALT) should be use as per protocol table on p.24of 69.
* Women of childbearing potential must have a negative pregnancy test
* Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
* Renal;urine protein:creatinine(UPC)ratio1.0 at screening or urine dipstick for proteinuria\<2+(patients discovered to have˃/=2+ protinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must …
What they're measuring
1
The primary objective is to obtain a RCB rate of 0-1 in at least 66%