Baseline features with clinical activity of the combination of ipatasertib plus HP. All PK variables will be summarised using the following descriptive statistics: Number of non-missing observations N.
Minimum, median, maximum. Eligibility Criteria. Inclusion Criteria: Written and signed informed consent for all study procedures according to local regulatory requirements prior to beginning of specific protocol procedures. Female pre- or postmenopausal or male patients. Wolff el al. JCO Patients with unresectable locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. Patients with available standard curative options are not eligible.
For patients with bilateral breast cancer, HER2-positivity must be demonstrated in both locations or in a metastatic biopsy. Patient must be a candidate to receive maintenance HP after first line treatment for metastatic disease with at least 4 cycles of taxane plus HP. Prior taxane must have been discontinued for a reason other than progressive disease.
Start of treatment with ipatasertib plus HP no later than 9 weeks after last dose of taxane plus HP i. Willingness and ability to provide archived formalin fixed paraffin embedded FFPE tissue block. Patients receiving coumarin derivatives should have an INR between 2. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after the last dose of investigational product.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin, carcinoma in situ of the cervix or Stage I uterine cancer.
Brain metastases that have not been treated previously, are progressive, or require any type of therapy e. Symptomatic hypercalcemia requiring use of bisphosphonate or RANKL inhibitors therapy within 21 days prior to the first study treatment. Patients who receive bisphosphonate therapy specifically to prevent skeletal events are eligible if they have been initiated prior to the treatment to study.
Cardiopulmonary dysfunction as defined by: Inadequately controlled angina or serious cardiac arrhythmia not controlled by adequate medication. History of myocardial infarction within 6 months prior to randomization. Current dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy. Concurrent, serious, uncontrolled infections or current known infection with HIV testing is not mandatory. History of intolerance, including Grade infusion reaction or hypersensitivity, to trastuzumab or pertuzumab.
Known hypersensitivity to any of the study drugs, including excipients. History of or active inflammatory bowel disease e. Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections Pneumocystis pneumonia or Cytomegalovirus pneumonia.
Uncontrolled pleural effusion, pericardial effusion, or ascites. Patients with indwelling catheters e. Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
Thank you! In the end, it saved me weeks worth of time. Buy it, use it, love it… you will not regret it. Thank you so much for this amazing product! Thank you for inventing something that actually works and is easy to use. The software works very well. It was stated on the Markzware website that a version for windows is being prepared, but this information is no longer there. Can any of the developers please write, so how will it be? Still nothing for ID So much time lost having to re-do old forms from scratch.
By far my biggest frustration with this product. Hello Michael. We understand your frustration with the lack of timely releases for the Windows Q2ID plug-in. We're in the process of replacing the plug-in with a stand-alone application, which will mean you don't need an update for every new version of InDesign. I'm sorry for the frustration in the meantime.
Q2ID did exactly what it promised. It's super easy to download and use. Just opened my Quark files in ID and I was ready to go. I didn't lose any time trying to figure out. The sales rep patiently answered all my questions and even ran a page test for me before I bought the software. I wish every company cared as much about their product as Markzware does. I'm happy converting all the QXD files to Indesign and word. It handles my pedigree boxes in great fashion so that I can keep them updated.
With the novel, I can select the words and paste them into Word, my choice for the move. Have used previous versions with great success. I am now using the latest version with CC It works perfectly with virtually everything. Very little paragraph reformatting. Sometimes the artwork would resize slightly when the artwork was rekindled to the original.
AI files. This was a HUGE timesaver! The program works as described, but the Q2ID program downloaded for InDesign CC also contains bugs that were found in earlier versions.
For example, in converted files, each textbox gets an external and an internal hold value. These must be repaired manually. It works well anyway, I recommend it to everyone! It's the fonts that you have to find in some cases. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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