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
NCORP, Members, Medical Oncologists, US INSTITUTIONS ONLY, Affiliates

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.

Publication Information Expand/Collapse

2023

Image analysis-based tumor infiltrating lymphocyte measurement predicts pathologic complete response to neoadjuvant chemotherapy in breast cancer (SWOG S0800)

K Fanucci;K Blenman;Y Bai;V Pelekanou;Z Nahleh;S Shafi;S Burela;W Barlow;P Sharma;A Thompson;A Godwin;D Rimm;G Hortobagyi;L Pusztai NPJ Breast Cancer May 13;9(1):38

PMid: PMID37179362 | PMC number: PMC10182981

2022

Prediction of pathologic complete response to neoadjuvant chemotherapy in breast cancer (SWOG S0800) using image analysis-based tumor infiltrating lymphocyte measurements

K Blenman;K Fanucci;Y Bai;V Pelekanou;Z Nahleh;S Shafi;S Burela;W Barlow;P Sharma;A Thompson;A Godwin;D Rimm;G Hortobagyi;L Pusztai J Clin Oncol 40, 2022 (suppl 16; abstr 594), poster 365; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

2020

Analysis of pre- and post-treatment tissues from the SWOG S0800 trial reveals an effect of neoadjuvant chemotherapy on the breast cancer genome

R Powles;V Wali;X Li;W Barlow;Z Nahleh;A Thompson;A Godwin;C Hatzis;L Pusztai Clinical Cancer Research Apr 15;26(8):1977-1984; Jan 9. doi: 10.1158/1078-0432.CCR-19-2405. Online ahead of print.

PMid: PMID31919134 | PMC number: PMC771064

2019

Immune profiling of pre- and post-treatment breast cancer tissues from the SWOG S0800 neoadjuvant trial

X Li;S Warren;V Pelekanou;V Wali;A Cesano;M Liu;P Danaher;N Elliott;Z Nahleh;D Hayes;G Hortobagyi;W Barlow;C Hatzis;L Pusztai Journal for ImmunoTherapy of Cancer Apr 10;7(1):88

PMid: PMID30967156 | PMC number: PMC6457012

2018

Tumor infiltrating lymphocytes and PD-L1 expression in pre- and post-treatment breast cancers in the SWOG S0800 Phase II neoadjuvant chemotherapy trial

V Pelekanou;W Barlow;Z Nahleh;B Wasserman;Y-C Lo;M-K von Wahlde;D Hayes;G Hortobagyi;J Gralow;D Tripathy;P Porter;RB Livingston;B Szekely;C Hatzis;DL Rimm;L Pusztai Molecular Cancer Therapeutics Jun;17(6):1324-1331; Mar 27 [Epub ahead of print]

PMid: PMID29588392 | PMC number: PMC6548451

Immune profiling of pre- and post-treatment breast cancer tissues from the SWOG S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide

X Li;S Warren;V Pelekanou;V Wali;M Liu;P Danaher;W Barlow;Z Nahleh;C Hatzis;L Pusztai J Clin Oncol 36, 2018 (suppl; abstr 578); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster session

2017

Effects of neoadjuvant chemotherapy (NAC) on tumor infiltrating lymphocytes (TIL) and PD-L1 expression in the SWOG S0800 clinical trial

V Pelekanou;W Barlow;M-C vonWahlde;B Wasserman;YC Lo;DF Hayes;G Hortobagyi;J Gralow;D Tripathy;RB Livingston;ZA Nahleh;DL Rimm J Clin Oncol 35, 2017 (suppl; abstr 519); American Society of Clinical Oncology (ASCO) Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

2016

SWOG S0800 (NCI CDR0000636131):Addition of bevacizumab to neoadjuvant nab-paclitaxel with dose–dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer

Z Nahleh;W Barlow;D Hayes;A Schott;J Gralow;E Perez;W Sikov;S Chennuru;H Mirshahidi;S Corso;D Lew;L Pusztai;R Livingston;G Hortobagyi Breast Cancer Research and Treatment Aug;158(3):485-495; 2016 Jul 8 [Epub ahead of print]

PMid: PMID27393622 | PMC number: PMC4963434

2014

Image registration for quantitative parametric response mapping of cancer treatment response

JL Boes;BA Hoff;N Hylton;MD Pickles;LW Turnbull;AF Schott;A Rehemtulla;R Chamberlain;B Lemasson;R Chenevert;CJ Galban;CR Meyer;BD Ross Translational Oncology 7(1):101-110;

PMid: PMID24772213 | PMC number: PMC3998680

S0800: Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim with or without Bevacizumab in Treating Women with Inflammatory or Locally Advanced Breast Cancer (NCI CDR0000636131)

Z Nahleh;W Barlow;D Hayes;A Schott;J Gralow;E Perez;W Sikov;S Chennuru;H Mirshahidi;S Vidito;D Lew;L Pusztai;R Livingston;G Hortobagyi San Antonio Breast Cancer Symposium, abstr. [P3-11-16]; poster presentation;