HonCode

Go Back   HER2 Support Group Forums > Clinical Trials
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 11-24-2014, 10:58 AM   #1
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Post Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk

Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (HER3+)
This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Cancer Insight, LLC
Sponsor:
Cancer Insight, LLC
Collaborators:
Genentech, Inc.
Galena Biopharma, Inc.
Information provided by (Responsible Party):
Cancer Insight, LLC
ClinicalTrials.gov Identifier:
NCT02297698
First received: November 14, 2014
Last updated: November 19, 2014
Last verified: November 2014
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone. Our target study population is high-risk HER2-positive breast cancer patients. High-risk HER2-positive breast cancer patients are defined as:

Those with HER2-positive breast cancer, regardless of hormone receptor status, who receive neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy, and fail to achieve a pCR.

Those with HER2-positive breast cancer, regardless of hormone receptor status, who undergo surgery as a first intervention and are found to have ≥ 4 positive lymph nodes.

Those with HER2-positive, hormone receptor negative breast cancer who undergo surgery as a first intervention and are found to have 1-3 positive lymph nodes.

Disease-free subjects after standard of care multi-modality therapy will be screened and HLA-typed.


Condition Intervention Phase
Breast Cancer
Biological: NeuVax vaccine
Drug: Trastuzumab
Drug: GM-CSF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase II Trial of Combination Immunotherapy With Nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in High-risk HER2+ Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Cancer Insight, LLC:

Primary Outcome Measures:
Invasive Disease-free survival (DFS) [ Time Frame: Initiation of trastuzumab monotherapy through the end of the patient's fifth year of participation in the study. ] [ Designated as safety issue: No ]
Compare invasive DFS between the two treatment groups from time of initiation of trastuzumab maintenance therapy (trasuzumab monotherapy) to time of invasive local, regional or distant recurrence, new primary, or death due to any cause. Disease state will be determined by the patients' own physicians at the individual study sites during their routine follow-up screening. This will occur for all enrolled patients, regardless of randomization, approximately every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary outcome measure of the trial is invasive DFS.


Secondary Outcome Measures:
Distant recurrence-free survival (DRFS) [ Time Frame: Initiation of trastuzumab monotherapy through the end of the patient's fifth year of participation in the study. ] [ Designated as safety issue: No ]
DRFS will be assessed as part of the patient's disease state as determined by their physician at the individual study sites during routine follow-up screening. Determination of DRFS will allow for continued follow-up on patients with local or regional recurrence.

Local and systemic toxicities [ Time Frame: From the date of initiation of the vaccine or inoculation series and booster series up to 36 months. ] [ Designated as safety issue: Yes ]
Standard local and systemic toxicities will be collected and graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 graded toxicity scale. For both the inoculations during the primary vaccine/inoculation series and the booster inoculations, patients will be monitored closely for one hour after inoculation with questioning, serial exams and vital signs every 15 minutes to observe for a hypersensitivity reaction. Additionally, patients will return to their study site 48-72 hours after inoculation for questioning regarding any systemic toxicity and local injection site reactions. When they return to their study site, the local reaction at the inoculation sites will be examined and measured.

Evaluate in vivo and in vitro immune responses [ Time Frame: From the date of the first inoculation of Trastuzumab monotherapy to the end of the patient's fifth year of participation in the study. ] [ Designated as safety issue: Yes ]
Immune responses will be primarily documented using the delayed type hypersensitivity (DTH) reaction and using the dextramer assay to enumerate peptide-specific CTL. Each of these measurements will be performed regardless of randomization. DTH reactions will be measured prior to initiation of the primary vaccine/inoculation series, one month ± 1 week after completion of the primary vaccine/inoculation series, and one month ± 1 week after the final booster inoculation. Dextramer measurements will be performed prior to initiating the primary vaccine/inoculation series as well as one month ± 1 week after completion of the vaccine/inoculation series. Additionally, these assays may be performed pre- and post-each booster. Alternatively, these assayed time points may also be performed all at once on frozen and banked cells.


Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab + NeuVax
Patients randomized to this arm will receive vaccinations of nelipepimut-S (1000 μg) and GM-CSF (250 μg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 12 months ± 2 weeks after the initiation of trastuzumab maintenance therapy, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following timepoints after initiation of trastuzumab maintenance therapy: 12 months ± 2 weeks, 18 months ± 2 weeks, 24 months ± 2 weeks and 30 months ± 2 weeks.
Biological: NeuVax vaccine
1000mcg of lyophilized E75 peptide is suspended in bacteriostatic water for injection and then frozen. At the time of vaccine administration, this frozen vial of suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the NeuVax vaccine. Patients randomized to this arm will receive vaccinations of nelipepimut-S/GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy.
Other Name: nelipepimut-S
Drug: Trastuzumab
Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first trastuzumab infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Trastuzumab will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk.
Other Name: Herceptin
Active Comparator: Trastuzumab + GM-CSF
Patients randomized to this arm will receive inoculations of GM-CSF (250 μg) administered in an identical manner to those receiving nelipepimut-S/GM-CSF (NeuVax). Patients will be blinded as to whether they are receiving nelipepimut-S/GM-CSF or GM-CSF alone. Upon completion of the primary vaccination series (PVS), booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 12 months ± 2 weeks after the initiation of trastuzumab maintenance therapy, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following timepoints after initiation of trastuzumab maintenance therapy: 12 months ± 2 weeks, 18 months ± 2 weeks, 24 months ± 2 weeks and 30 months ± 2 weeks.
Drug: Trastuzumab
Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first trastuzumab infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Trastuzumab will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk.
Other Name: Herceptin
Drug: GM-CSF
For patients randomized to the GM-CSF alone arm, they will receive inoculations of GM-CSF (250mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first injection will be given with the third dose of maintenance trastuzumab administered as monotherapy.
Other Names:
Leukine
Sargramostim

Detailed Description:
In this study, the investigators intend to assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant GM-CSF) given in the adjuvant setting to prevent recurrences in patients with high-risk HER2-positive breast cancer. High-risk is defined as those patients that do not achieve a pCR after neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy or those who undergo upfront surgery and are found to have greater than or equal to four positive lymph nodes regardless of hormone receptor status or 1-3 positive lymph nodes and are hormone receptor negative.

Following surgery, patients will be screened and HLA-typed (consent #1). Nelipepimut-S is a CD8-eliciting peptide vaccine that is restricted to HLA-2+ or HLA-A3+ patients (approximately two-thirds of the US population). HLA-A2+ and/or A3+ patients who meet all other eligibility criteria will be randomized to receive trastuzumab + nelipepimut-S/GM-CSF or trastuzumab + GM-CSF alone (consent #2). The trastuzumab will be administered to all patients consistent with current standard of care. Patients randomized to the nelipepimut-S/GM-CSF arm will receive vaccinations of nelipepimut-S (1000 mcg) and GM-CSF (250 mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy. Patients randomized to the GM-CSF alone arm will receive inoculations of GM-CSF (250 mcg) administered in an identical manner to those receiving nelipepimut-S/GM-CSF. Patients will be blinded as to whether they are receiving nelipepimut-S/GM-CSF or GM-CSF alone.

Upon completion of the primary vaccination/inoculation series, booster inoculations (same dose and route) will be administered every six months x 4. The first booster inoculation will occur 12 months ± 2 weeks after the initiation of trastuzumab maintenance therapy, with subsequent boosters timed every six months + 2 weeks. Boosters will therefore occur at the following timepoints after initiation of trastuzumab maintenance therapy: 12 months ± 2 weeks, 18 months ± 2 weeks, 24 months ± 2 weeks and 30 months ± 2 weeks. Booster inoculations will occur for patients randomized to receive nelipepimut-S/GM-CSF as well as patients randomized to receive GM-CSF alone, and will consist of the same treatment drugs and dosing (i.e. nelipepimut-S/GM-CSF patients will be boosted with nelipepimut-S/GM-CSF while GM-CSF alone patients will be boosted with GM-CSF alone). Patient blinding will be maintained throughout the study.

Subjects will be followed for safety issues, immunologic response and clinical recurrence. Patients will be monitored 48-72 hours after each inoculation for reaction to the inoculation as well as documentation of any adverse effects experienced. Immunologic response will be monitored primarily by in vivo delayed type hypersensitivity (DTH) reactions but also may be documented by other immunologic assays. All patients will be followed for a total of 36 months from the time of initiation of trastuzumab maintenance therapy to document disease-free status.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion criteria:

18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status 0,1
AJCC stage I - III non-inflammatory, HER2-positive (according to ASCO-CAP guidelines 5) breast cancer
Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible) or underwent surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status or 1-3 positive lymph nodes (pN1) if hormone receptor negative. Patients with micrometastases (pN1mi) are not eligible.
Completed an approved regimen of neoadjuvant or adjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy with plan for completion of one year of trastuzumab therapy.
Completed appropriate surgical therapy to include:
Total mastectomy and axillary staging with sentinel lymph node dissection or axillary lymph node dissection (level I/II). Patients with a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
Breast conserving surgery (BCS) and axillary staging with sentinel lymph node dissection or axillary lymph node dissection. Patients undergoing surgery as a first intervention with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes. Patients receiving neoadjuvant chemotherapy that have a positive sentinel lymph node must have undergone a completion axillary lymph node dissection.
Completed or receiving appropriate radiation therapy if indicated:
For patients undergoing surgery (total mastectomy) as a first intervention, post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.

For patients undergoing surgery (BCS) as a first intervention, whole breast irradiation with or without a boost, and radiation to the infraclavicular and supraclavicular areas is required for patients with ≥ 4 positive lymph nodes. Radiation to the internal mammary lymph nodes is not required but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 1-3 positive lymph nodes, whole breast irradiation with or without a boost is required. Radiation to the infraclavicular, supraclavicular, and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating medical oncologist.
For patient's undergoing mastectomy after neoadjuvant chemotherapy post-mastectomy radiation to the chest wall, infraclavicular and supraclavicular areas is required for patients presenting with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, post-mastectomy radiation to the chest wall, infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
For patient's undergoing BCS after neoadjuvant chemotherapy, whole breast irradiation with or without a boost is required. For patients with clinical N2 or N3 disease or with ≥ 4 positive lymph nodes identified pathologically at the time of surgery, radiation to the infraclavicular and supraclavicular areas is required. Radiation to the internal mammary lymph nodes is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist. For patients with 0-3 positive lymph nodes identified pathologically, radiation to the infraclavicular, supraclavicular and internal mammary areas is not required per protocol but is allowed at the discretion of the patient's treating radiation oncologist.
HLA-A2 and/or HLA-A3 positive
LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or ECHO)
Adequate organ function as determined by the following laboratory values:
ANC ≥ 1,000/μL
Platelets ≥ 75,000/μL
Hgb ≥ 9 g/dL
Creatinine ≤ 1.5 x upper limit of normal (ULN) of institution's range or Creatinine clearance ≥ 50%
Total bilirubin ≤ 1.5 ULN of institution's range
ALT and AST ≤ 1.5 ULN of institution's range
For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
Signed informed consent
Exclusion criteria:

AJCC Stage IV breast cancer
NYHA stage 3 or 4 congestive heart failure
Immune deficiency disease or known history of HIV, HBV, HCV
Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
Pregnancy (assessed by urine HCG)
Breast feeding
History of autoimmune disease
Active pulmonary disease requiring medication to include multiple inhalers (>3 inhalers including one containing steroids)
Involved in other experimental protocols except with permission of other PI
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02297698

Locations
United States, Indiana
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Lori Wiseman, CCRP 574-647-6821 lwiseman@beaconhealthsystem.org
Principal Investigator: Thomas Reid, III, MD, PhD
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Holly Simmons, RN, BSN 713-792-6491 hsimmons@mdanderson.org
Principal Investigator: Elizabeth A. Mittendorf, MD, PhD, FACS
United States, Washington
Providence Regional Medical Center Recruiting
Everett, Washington, United States, 98201
Contact: Katie Lyon, CCRP 425-297-5531 katie.lyon@providence.org
Principal Investigator: Jason Lukas, MD
Sponsors and Collaborators
Cancer Insight, LLC
Genentech, Inc.
Galena Biopharma, Inc.
More Information

No publications provided

Responsible Party: Cancer Insight, LLC
ClinicalTrials.gov Identifier: NCT02297698 History of Changes
Other Study ID Numbers: 2014-0443
Study First Received: November 14, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer Insight, LLC:
Breast cancer, NeuVax

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014
'lizbeth is offline   Reply With Quote
Old 11-24-2014, 11:00 AM   #2
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

3 trial locations:

Dr. Mittendorf's in Houston, TX
Also in Everett, WA and South Bend, IN
'lizbeth is offline   Reply With Quote
Old 11-24-2014, 11:56 AM   #3
MargaretAlice
Member
 
Join Date: Nov 2014
Posts: 10
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

I spoke with E. Mittendorf's research nurse. I understood this to be a Phase III trial with 50 slots (maybe 50 at MD Anderson?). The criteria match what I was told.
MargaretAlice is offline   Reply With Quote
Old 11-24-2014, 12:06 PM   #4
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

Well bless my little pessimistic soul, I was just telling James that I didn't think there would be another vaccine trial anytime soon.

However, I think he has an angel on his shoulder because I just got the unofficial word of a second trial for after Herceptin is finished.

I copied and pasted the information from clinicaltrials.gov

Perhaps the phase III trial with the 50 slots is for post Herceptin vaccine trial. If I remember correctly the phase II has been finished already.


Several participants in the AE37/GP2 trial mentioned "that lady from San Diego". Thank you, Thank you, Thank you for participating with me.

If you even think that you might qualify, or not. Make the call for information on the vaccine trials.

Thanks again,

Elizabeth

Last edited by 'lizbeth; 11-24-2014 at 12:09 PM.. Reason: clarification
'lizbeth is offline   Reply With Quote
Old 11-24-2014, 12:29 PM   #5
mscaruso
Member
 
Join Date: Apr 2014
Posts: 6
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

'Lizbeth - forgive me - where did you post it? And is it enrolling right now or will be in the future? Thanks!
mscaruso is offline   Reply With Quote
Old 11-24-2014, 12:38 PM   #6
MargaretAlice
Member
 
Join Date: Nov 2014
Posts: 10
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

Spent part of last week at MD Anderson, eval by MO. Recommendation was the ATEMPT clinical trial.

I am very interested in immunotherapy. If I had qualified, I was there at the right time to put my name in the hat. The clinical nurse supporting the MO was also closely following the upcoming NeuVax trial. I think we chimed in together on the 4 positive node requirement, eliminated another patient from consideration. Mittendorf's research nurse suggested I watch for any info published about a different vaccine, "AE37".
MargaretAlice is offline   Reply With Quote
Old 11-24-2014, 12:55 PM   #7
MargaretAlice
Member
 
Join Date: Nov 2014
Posts: 10
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

http://www.mdanderson.org/patient-an...son/index.html

The NeuVax clinical trial will be led by Elizabeth Mittendorf.


2011-0595(clinicaltrials.gov NCT No: NCT01479244) Title:PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive
Breast Cancer with Low to Intermediate HER2 Expression with
NeuVax Treatment
Principal Investigator:Elizabeth A. Mittendorf Treatment Agent:GM-CSF; NeuVax Study Status:Open Study Description:The goal of this part of the clinical research study is to learn more about the
amounts of the HER2 protein in patients who had breast cancer using the Bond
Oracle HER2 IHC System.
MargaretAlice is offline   Reply With Quote
Old 11-25-2014, 09:24 AM   #8
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

Remy just emailed that the information is indeed on Clinicaltrials.gov

Below is the new trial for us higher expressors who are at high risk of recurrence.
There are currently 3 sites: Houston TX, Everett WA, and Southbend IN
Please note that additional sites are planned for the future.

Quote:
Thank you again for your interest and patience in this trial. The trial is now listed on Clinical Trials under NCT02297698 and here is the link: http://clinicaltrials.gov/ct2/show/N...=neuvax&rank=1. The trial has just begun and will have additional sites over time.

I hope you have a wonderful Thanksgiving.
'lizbeth is offline   Reply With Quote
Old 11-25-2014, 09:30 AM   #9
'lizbeth
Senior Member
 
'lizbeth's Avatar
 
Join Date: Apr 2008
Location: Sunny San Diego
Posts: 2,214
Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r

To clarify who is consider High Risk

1) Neoadjuvant treatment with residual disease found at surgery

Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible)

2) Surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status

3) 1-3 positive lymph nodes (pN1) if hormone receptor negative.

So if you are agonizing because you did not get a complete response to chemo before surgery, if you had 4 or more positive nodes, OR if you are ER-/PR-/HER2+ and had 1-3 positive nodes - this is a great option for you.

Thanks and keep us posted on if you could or could not enroll.
'lizbeth is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 06:09 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2017, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007
free webpage hit counter