SWOG clinical trial number
S0800
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Closed
Phase
Accrual
100%
Published
Abbreviated Title
ADVANCED: Phase II weekly Nab-Paclitaxel +/- Bevacizumab, Preceded or Followed by AC+PEG-G for Locally Advanced Her-2/Neu Neg Breast Cancer
Activated
04/01/2010
Closed
10/01/2012
Participants
Research committees
Breast Cancer
Treatment
Cyclophosphamide
Doxorubicin
Bevacizumab
Pegfilgrastim
Nab-Paclitaxel
Eligibility Criteria Expand/Collapse
Pts must be women with a histologically or pathologically confirmed diagnosis of Her-2 negative inflammatory breast carcinoma or Her-2 negative locally advanced breast carcinoma (Stage IIIB, Stage IIIA/IIB disease or Stage IIIC) and known receptor status. Her-2 negativity may be demonstrated by 0 or 1+ DAKO, IHC test or equivalent (weak or no staining), or by FISH (which shows no amplification). Patients with 2+ on DAKO or IHC will be eligible if FISH negative. For this protocol, a negative FISH test ratio < 1.8 or FISH Her 2 gene copy less than 4.0. If only a positive or negative result is available from the FISH test, then a negative result is acceptable for eligibility. Pts must not have received any prior chemotherapy, radiation therapy, or biologic therapy (e.g. trastuzumab, bevacizumab, etc.) for invasive breast cancer within the past 5 years. Pts may not have received prior anthracyclines for any reason. Prior hormonal therapy is allowed, but should be stopped at least 7 days prior to initiation of protocol treatment. Bisphosphonate therapy is allowed, when appropriate. Pts must have a Zubrod Performance Status of 0 to 2. Pts must not have any history of stroke or a cardiac event within 6 months prior to registration such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic CHF, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. Pts who have received central thoracic radiation that included the heart in the radiotherapy port, or have a history of Class II heart failure but who are asymptomatic on treatment, are eligible provided they have New York Heart Association Class II cardiac function on baseline ECHO/MUGA. Pts with hypertension or age > 60 years must have a MUGA or echocardiogram (ECHO) performed within 42 days prior to registration and LVEF % must be >/= ILLN. 6. Pts must have adequate hematologic values documented by a platelet count > 100,000 mcL, hemoglobin > 9.0 g/dL and ANC >/= 1500 cells/mcL within 28 days prior to registration. Pts must be given opportunity to consent to optional specimen submissions. Pts must have adequate renal function as documented by a serum creatinine </= 1.5 x IULN within 28 days prior to registration. UPC ratio > 0.5, 24 hour urine protein must be obtained and the level must be < 1000mg. Urine protein and creatinine used to calculate must be obtained within 28 days prior to registration. Pts must have adequate hepatic function obtained within 28 days prior to registration with bilirubin </= 1.5mg/dL, ALT and AST </= 2.5 x IULN, alkaline phosphatase </= 2.5 x IULN. Pts must have < Grade 2 pre-existing peripheral neuropathy. Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women of
reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of this trial. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years. Pts must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.
reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of this trial. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years. Pts must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.
Publication Information Expand/Collapse
2023
PMid: PMID37179362 | PMC number: PMC10182981
2020
PMid: PMID31919134 | PMC number: PMC771064
2019
PMid: PMID30967156 | PMC number: PMC6457012
2018
PMid: PMID29588392 | PMC number: PMC6548451
2016
2014
Image registration for quantitative parametric response mapping of cancer treatment response
PMid: PMID24772213 | PMC number: PMC3998680
Other Clinical Trials
SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
9%
Open
Phase
SWOG Clinical Trial Number
S2212
TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Research Committee(s)
Breast Cancer
Activated
07/21/2023
Accrual
16%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-BR007
A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer
Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase