Author s response to reviews

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1 Author s response to reviews Title: A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study): study protocol for a randomized controlled trial. Authors: Philip Schouten (philip.schouten@gmail.com) Gwen Dackus (g.dackus@nki.nl) Serena Marchetti (s.marchetti@nki.nl) Gabe Sonke (g.sonke@nki.nl) Jan Schellens (j.schellens@nki.nl) Sabine Linn (s.linn@nki.nl) Version: 1 Date: 17 Mar 2016 Author s response to reviews: Subject: A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study): study protocol for a randomized controlled trial. Amsterdam, March 15th, 2016 Dear dr. Saad,

2 We thank you for considering our manuscript A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1 or -2 mutated Her2 negative advanced breast cancer as first line treatment (REVIVAL study): study protocol for a randomized controlled trial. and the opportunity to revise it, and the reviewer for his thoughts on the improvement of the manuscript/protocol. In addition to answering the reviewers questions we have added the requested changes to adhere to the journal style. Please find attached a point by point answer to the reviewers, as well as any changes we have incorporated in the text. We also added a track changes version of the manuscript, marking the changes that we made in the revision process. We hope that these additions and answers are a sufficient enhancement to consider it for publication in Trials. Yours sincerely, Sabine C. Linn, MD, PhD Divisions of Molecular Pathology and Medical Oncology Plesmanlaan CX Amsterdam The Netherlands s.linn@nki.nl Telephone number:

3 Fax number: Reviewer 1. - Mansucript page 5 lines 44, suggested rewording -Page 9 line 25 (same page 10 line 23)- the eligibility requirement for prior exposure to anthracycline and taxane is a bit unclear and could benefit from more clarity. By following the label of existing therapy options in the metastatic setting we aim to deliver evidence that could be used for registration if the trial would demonstrate superiority of the experimental arm. Therefore we strictly follow the label that indicates that monotherapy capecitabine is indicated after failure of both taxanes and anthracycline containing chemotherapy. We agree that as little restrictions are best for inclusion, but not following current labels would result in uncertainty of superiority of the experimental regimen and thus negatively impact a potential registration. We adjusted the text for clarity: Page 9. patients must have BRCA1 or -2 -mutated HER2-negative breast cancer. Pretreatment should consist of an anthracycline and taxane in the (neo-)adjuvant setting (unless not indicated) following the label for capecitabine monotherapy in the metastatic setting but without systemic chemotherapy pre-treatment for advanced disease and with maximally two lines of hormonal therapy pre-treatment in the advanced setting Page 10 Pretreatment should include an anthracycline and taxane in the (neo-)adjuvant setting (unless not indicated) following the label for capecitabine monotherapy in the metastatic setting.

4 - The selected dose of capecitabine, is not the dose most commonly used in the US. I would recommend the authors use very liberal with dose reduction schemes here. Indeed, in the RESILIENCE registration study comparing capecitabine with or without sorafenib, the 1000mg/m2 dose was selected since that is what is used internationally more commonly. The dose was chosen according to the label. We are restricted to two options: starting at the registered dose and dose reducing or starting at the lower dose. The first option will result in dose reductions (in our clinical experience for approximately 1/3 of the patients). The second option, however, will always yield the criticism that we chose an inadequate dose that may favor the experimental arm and thus impact negatively applications for registration. Dose reductions are allowed according to a prescribed schedule. Page 10 are compared to registered standard of care capecitabine (1250 mg/m2 BID d 1-14 in 21 day cycles, according to the label) Page 12 Dose modifications for capecitabine (31), eribulin (32), paclitaxel (33) and vinorelbine (34) are allowed according to prespecified steps that follow the label - Eribulin starting dose is not the standard 1.4 mg/m2. Please clarify? Also, spelling of eribulin was incorrect on figure 2. This is the difference between formulation between US and Europe. The starting dose of eribulin is 1.23 mg/m2 which is equivalent to 1.4 mg/m2 eribulin mesylate. Page 11 After progression, patients will receive physician s choice of intravenous (IV) eribulin (1.23 mg/m² d1,8/21, equivalent to 1.4 mg/m2 of eribulin mesylate),

5 We corrected the spelling of eribulin in Figure 2. - Page 11 line 21 - note that in the metastatic setting it is common to interject a week off for weekly regimens such as paclitaxel or vinorelbine. As above, I would recommend the authors use a liberal flexible dose modification scheme for treating physicians to better match the real world practice. On page 12 line 9, are these modifications proscribed or per MD choice? The steps are pre-specified. Similar to the question regarding the starting dose, we have to choose not to allow weeks off, to prevent the criticism of inadequately dosing the control arm favoring the experimental treatment. The adjustment of the text is the same as the previous comment. - Page 11 line 38- is it correct that labs and exam will only be done once every 2 cycles beyond cycle 5? This is not typical. Minimum requirements are mentioned, allowing for some flexibility regarding long-term responders with minimal problems. If medically indicated more visits are allowed. Patients may be seen by physician assistants/nurse practitioners in the meantime. Page 11 Subsequently, patients will be followed with hospital visits for safety assessment comprising of medical history taking, physical examination and laboratory testing every cycle from cycle 1 until 4, and minimally every 2 cycles from cycle 5 onwards, unless more visits are medically indicated - Page 12 line 15 - Please clarify if the PK is only for part 1 or also part 2 PK measurements will only be conducted in part 1.

6 Page 12 Blood samples for olaparib and/or carboplatin PK will be drawn in Part 1 cycle 1 to capture the single agent, single-dose olaparib PK curve and the PK curves of olaparib and carboplatin in combination treatment. - For the statistical design, 104 events in 110 patients does not leave much room for dropout or other problems. In addition, as the authors note, many patients have had prolonged and durable responses to olaparib monotherapy. Therefore, it may take much longer than anticipated to see 104 events in 110 patients. The authors may want to consider a landmark analysis after some time point given this possibility. We agree with this observation and also discussed these possibilities with the study statistician. We expanded the text with extra information on the assumptions. Page 13 These calculations assume an exponential distribution of the progression free survival. A prespecified interim analysis will be performed when 52 events are observed, in case of futility of efficacy phase-ii will be prematurely terminated. Given the assumptions, it is expected that the interim analysis occurs after approximately 16 months and the final analysis after 30 months. If these assumptions are not met during the trial, the optimal course of adjustment (e.g. interim analysis at fixed time point rather than after a specific number of events or an adjustment of the modeling assumptions) will be decided in collaboration with an independent data safety monitoring board. No sample size calculation was performed for second line treatment. - Some comment is warranted as to how 4 months was chosen for the control arm PFS. While this is reasonable, it may be significantly impacted by the frequency of ER+ and ER-. In fact, it is probably appropriate to consider ER status a stratification factor. This was not addressed but should be. Little is known about PFS on first-line capecitabine monotherapy for triple negative breast cancer. Most studies either assessed capecitabine in the general breast cancer population (with triple negative being a minority of the patients), combined with other agents or combined treatment lines. We expect to include more triple negative patients (BRCA1-associated) than ER positive patients (more BRCA2-related) due to their relative prevalences. Combined with the following studies we estimated the median PFS to be 4 months:

7 Gelmon et al. report a time to progression, of single-agent capecitabine after anthracycline of approximately four months and a range of 3.0 to 4.9 months after anthracycline and taxane containing chemotherapy (pmid ). Isakoff summarized the literature (including conference presentations) and reported 1.7 months and 4 months of PFS in TNBC on capecitabine monotherapy (pmid ). Fan et al randomized metastatic, anthracycline pretreated patients, with taxane pre-treatment allowed but not required, to first line docetaxelcisplatin vs. docetaxel-capecitabine (1000 mg 2w on 1w off) and observed 4.8 months PFS (pmid ). Babacan et al retrospectively investigated patients that received first-line monotherapy capecitabine and found a strong separation of survival times by ER status with TN patients having a PFS of 4 months (pmid ). Blum et al (pmid ) pooled 7 studies and found 4.9 months PFS but also a strong benefit of capecitabine in hormone receptor positive disease which comprised 80% of the first line cohort. The expected PFS for TN disease, although not specifically mentioned, will be less than that. We agree with the reviewer that it would be appropriate to stratify patients by hormone receptor status. Snce this is a multi-center trial we also will stratify for treating center. New text on page 13 In Part 2, 104 events need to be observed to detect a clinically meaningful improvement in PFS1 from a median of 4 months (control arm,) to a median of 7 months (experimental arm) with a power of 80% (2-sided significance level of 5%). These assumptions are based on a mostly triple negative population, due to BRCA1-mutated cancers, and a 4-5 month expected benefit of capecitabine depending on the baseline characteristics, with a reported smaller time to progression of triple negative patients (35 39). New text on page 13: Patients will be stratified by treating center and by hormone receptor status. -Page 15 line 35 - see comment in manuscript. In summary, I think it would be worthwhile to address the additional hypothesis supporting this trial design in which jump-starting the DNA damage in cells with platinum may make cells more sensitive to PARP inhibitors. I think this is a compelling rationale for this study and worth mentioning either in the background or discussion.]

8 The reviewer is correct that we addressed the mechanism of synergy little, except for mentioning the reports on potential synergistic effects. This is in part due to incomplete mechanistic understanding (DeLorenzo & Helleday), of PARP inhibition on HR deficient cells. All of the currently proposed models have characteristics that allow predictions for experiments. These experiments have been partially not done or have generated results that are inconsistent with the predictions. For example, focusing only on PARP1 expression, models, either would predict highest sensitivity in PARP1-overexpressed (trapping) or PARP1-depleted (inhibiting catalytic) samples. Strom and Helleday (Biomolecules 2012) summarize the options in which combinations of PARP inhibition and other drugs could yield tumor cell killing and toxicity. Firstly, two types of damage may be more effective than a single source, even though combining likely results in lower doses of both drugs. Secondly, PARP expression may be induced by DNA damage (Strom and Helleday) sensitizing tumors to olaparib by making more target available to inhibit/trap. However, Helleday also describes that HR deficient cells already contain high levels of PARP1 at the replication fork during S phase, possibly not requiring a jump-start. Unfortunately we won t be able to formally test this hypothesis or the lag-time with the proposed setup (most naïve trial design: carbo-carbo-ola-ola vs. ola-ola-carbo-carbo). New text page 6 Although limited by bone marrow toxicity, it may be that combining two types of damage is more effective than overloading a cell with only one type of damage mechanism. Furthermore, sensitization to olaparib may occur for example, due to DNA damage induced PARP1 expression (16,17,28). Page 16 line 8 - while the authors are correct that capecitabine is the approved agent, there are still significant limitations in choosing capecitabine as the comparator over carboplatin alone. Notably, it is not clear if the carbo/parp approach is the same or better than carbo alone. In addition, there is little data in BRCA carriers for capecitabine and so the authors probably had more flexibility than they describe. Nevertheless, this is a reasonable design. We have chosen registered choices to allow for quick approval by authorities; by choosing nonregistered choices (for example carboplatin) a positive result would not immediately make olaparib available for clinical use. Capecitabine remains a robust registered choice and there are no data suggesting that BRCA mutation carriers should not be offered capecitabine. - The funding is described at the very end, but it is still a bit unclear if this is an investigator initiated protocol, or if it is AZ initiated. In addition, some comment should be included about

9 how many sites will participate since 110 first line carriers will be hard to find unless multiple sites are involved. The ongoing phase 3 registration studies (OlympiAD, BROCADE, Etc should provide some idea). The protocol is investigator initiated and funded by AstraZeneca. New text page 2 and page 7: This investigator initiated study contains two parts. Regarding the number of centers, we are recruiting Dutch and international sites. At the moment we have between 20 and 30 sites, but negotiations are ongoing, which is why we did not specify numbers other than that part 2 is going to be multicenter in multiple countries to gather the required population (page 15). Handling editor comments: "I would add one additional concern to the issue on sample-size calculation already pointed out by the referee: in addition to explaining why the number of patients to be enrolled is only slightly larger than the required number of events (is it because they will observe nearly all patients until progression, something that may delay the analysis for quite a long time?), authors should make it explicit whether the interim analysis will be performed using formal statistical rules for the interim look and with the aim of preventing inflation of the type I error in case the study continues after this analysis." In line with the questions by reviewer one we expanded the statistical sample size calculations. Since the sample size calculations rely on different assumptions (amongst others: accrual rate, interim analysis, survival distribution) that were deemed reliable the study statistician suggested to not change these calculations. If during the trial it seems that goals are not reached we will consult the data safety monitoring board to decide the appropriate course of action without breaking statistical rules.

10 Editorial requests: 1. Please ensure the title conforms to journal style for study protocol articles. The title should follow the format : study protocol for a randomized controlled trial. Please note that the title in the submission system should match that of your manuscript. We adjusted this. 2. Please include the addresses of all authors on the title page. We added these. 3. For additional files, please ensure that you list the following information after your reference section in your manuscript: Additional files: File name (e.g. Additional file 1) File format including the correct file extension for example.pdf,.xls,.txt,.pptx (including name and a URL of an appropriate viewer if format is unusual) Title of data Description of data Additional files should be named "Additional file 1" and so on and should be referenced explicitly by file name within the body of the article, e.g. 'An additional movie file shows this in more detail [see Additional file 1]'. We added this section and added a reference to the additional file in the text.

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