Triple Negative Breast CancerPhase 1PAveMenTNCT04360941
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
A Phase 1 study testing Palbociclib and Avelumab in people with Triple Negative Breast Cancer and Locally Advanced Breast Cancer, run by Royal Marsden NHS Foundation Trust at 9 sites in United Kingdom.
Trial summary
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab. The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- Palbociclib and Avelumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 11 Aug 2020to 31 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recurrent inoperable locally advanced or metastatic breast cancer.
- Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.
- Measurable disease (RECIST 1.1)
- Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
- Women/female patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- Women/females of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women/female patients) or 14 weeks (men/male patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:
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- Oral, intra-vaginal or transdermal combined hormonal contraception
- Oral, injectable or implantable progesterone-only contraception
- Intrauterine device
- Intrauterine hormone-releasing system,
- Bilateral tubal occlusion
- Vasectomised partner
- True abstinence:* When this is in line with the preferred and usual lifestyle of the subject
- Key: it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments
- 18 years of age or over.
- World Health Organisation (WHO) performance status 0 or 1
- Estimated life expectancy of at least 3 months in the opinion of the investigator
- Signed and dated informed consent.
- Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures
- Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER/PgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.
- Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.
- Measurable disease (RECIST 1.1) amenable to fresh biopsy
- Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
- Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- Women/females of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women/female patients) or 14 weeks (men/male patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:
- Oral, intra-vaginal or transdermal combined hormonal contraception
- Oral, injectable or implantable progesterone-only contraception
- Intrauterine device
- Intrauterine hormone-releasing system,
- Bilateral tubal occlusion
- Vasectomised partner
- True abstinence:* When this is in line with the preferred and usual lifestyle of the subject
- Key: it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments
- Age 18 years of age or over
- World Health Organisation (WHO) performance status 0 or 1
- Estimated life expectancy of at least 3 months in the opinion of the investigator
- Signed and dated informed consent
- Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures
- Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)
- Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)
Who cannot join
- Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.
- Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.
- Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and/or adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.)
- Previous treatment with palbociclib or any agents which inhibit CDK4/6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.)
- Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry
- Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.
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- Active infection requiring systemic therapy
- Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.
- Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.
- Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
- Inability or unwillingness to swallow pills, or receive IV injections.
- Persisting toxicity related to prior therapy >Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).
- Pregnancy or lactation (women/females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)
- Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
- Known prior or suspected hypersensitivity to investigational products or to any of the excipients
- Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab.
- Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator.
- Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Hope Clinical Trials Cancer Centre
Leicester, LE1 5WW
Barts Cancer Institute
London, EC1M 6BQ
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Nottingham University Hospital
Nottingham, NG5 1PB
Weston Park Hospital
Sheffield, S10 2SJ
About this study
Official title: PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.
The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.
It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.
Read the detailed description
This is a phase Ib study designed to confirm the safety and evaluate the efficacy of palbociclib combined with avelumab in AR positive TNBC. It is a multi-centre study design (it will run at several hospitals in the UK).
Palbociclib inhibits two proteins involved in cell growth called cyclin dependent kinase 4 and cyclin dependent kinase 6 (CDK4/6). Inhibiting CDK4/6 stops cells, such as cancer cells, from dividing and multiplying further. Palbociclib is currently approved for the treatment of metastatic HR positive HER2 negative breast cancer, based on good results from large clinical trials. Laboratory studies have shown that palbociclib might be also useful in some patients with triple negative breast cancer, an aggressive subtype of breast cancer that does not express the hormone receptors or HER2 receptor, but only if the cancer is positive for the androgen-receptor (AR).
Avelumab is an immunotherapy drug which does not destroy cancer cells, but tries to stimulate the body's immune system to do this. Avelumab has been tested in a number of different types of tumours including breast cancer, but although approved for use in the USA, it is not currently an approved standard treatment in the UK. The combination of both drugs has never been tested in humans before.
Recruitment to Part A will be conducted only at the Royal Marsden Hospital and Part A of the study will establish the maximum tolerated dose (MTD) and optimal schedule of the combination in any suitable patients with advanced breast cancer. Once this dose schedule has been confirmed, the chosen dose level will be recruited to, aiming to include 27 patients with AR positive TNBC (Part B).Part B will recruit at up to 8 high volume centres. The androgen receptor is not routinely tested for in hospital laboratories, so patients with advanced triple negative breast cancer who are interested in taking part in the study will be asked to provide consent for previously taken cancer samples/biopsies to be sent to the Royal Marsden for testing, to see if the cancer expresses the androgen receptor, which would make participants potentially eligible for part B of the study. Approximately 20% of triple negative breast cancers express AR. This phase of the study will include important translational work using new cancer samples (biopsies) and blood samples to investigate potential "biomarkers" -predictors of efficacy and resistance to the combination.
In Part A of the study, patients with previously treated, advanced breast cancer will have an ECG (heart trace) a CT scan of the body and potentially an MRI scan of the brain and a bone scan (depending upon where the breast cancer is known to have spread to) as well as blood tests to determine if participants are suitable for the study.
During the study participants will receive daily palbociclib tablets and intravenous infusions of avelumab every two weeks. Participants will be monitored with regular blood tests and repeat CT scans every 8 weeks. At whatever time point the treatment stops working, the patient will stop treatment and will be asked to have further blood tests one month later as well as a check up with the study doctor.
In Part B of the study, patients with triple negative histology and positive androgen receptor status tested at the Royal Marsden will be required to have a cancer biopsy before participants start treatment on the study. LIke in Part A, participants will also have an ECG (heart trace)a CT scan of the body and potentially an MRI scan of the brain and a bone scan (depending upon where the breast cancer is known to have spread to) as well as blood tests to determine if participants are suitable for the study. During the study participants will receive daily palbociclib tablets and intravenous infusions of avelumab every two weeks. Participants will be monitored with regular blood tests and check-ups with the study doctor and repeat CT scans every 8 weeks as well as additional blood tests for research. After 3 weeks of treatment, the patient may have a further tumour biopsy, which is optional. At whatever timepoint the treatment stops working, the patient will stop treatment and will be asked to have further blood tests and a further biopsy. Participants will also have a check-up with the study doctor and blood tests one month later.
A maximum of 45 breast cancer patients will be enrolled; up to 18 patients in part A and 27 patients with AR+ triple negative breast cancer in part B.
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast Cancer, ER+ Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Palbociclib, Avelumab
- Keywords
- Palbociclib, Avelumab, Measurable Disease, Inoperable Disease
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Highly selective oral inhibitor of CDK4 and CDK6.
AvelumabDrug
Also called Bavencio
Fully human IgG1 monoclonal antibody (mAb) binds to the PD-L1 cell surface ligand and blocks its interaction with the PD-1 cell surface receptor.
| Study group | Role | What they receive |
|---|---|---|
| Two-part phase 1b trial of induction palbociclib with avelumab | Experimental | Recruitment to Part A will be conducted at the Royal Marsden Hospital only. Up to 18 patients will be recruited for dose escalation of palbociclib in combination with fixed dose avelumab.
Part B will recruit at up to 8 high volume centres. Up to 27 patients will be recruited to treatment with the maximum tolerated dose and schedule established in part A. In Part B of the study, additional selection by triple negative histology and positive androgen receptor status will define the study population. Receives: Drug: Palbociclib; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Determine maximum tolerated dose (MTD) of palbociclib plus avelumab in advanced breast cancer
Define MTD of palbociclib delivered in combination with avelumab
Measured: 18 month recruitment period
Part B: Determine the confirmed objective response rate of AR+ TNBC patients treated with palbociclib plus avelumab
Response rate assessed by RECIST 1.1 by local radiology review
Measured: Up to 24 month recruitment period
Secondary outcomes (4)
Determine the clinical benefit rate (CR/PR/SD for a minimum of 24 weeks) in AR+ TNBC patients treated with palbociclib plus avelumab
Clinical benefit rate (response or stable disease lasting at least 24 weeks), assessed by RECIST 1.1 by local radiology review.
Measured: Total 42 month recruitment period
Determine the median PFS in AR+ TNBC patients treated with palbociclib plus avelumab
Progression-free survival, calculated from day 1 of study treatment to the date of radiological disease progression or death from any cause.
Measured: Total 42 month recruitment period
Assess the safety and tolerability of palbociclib plus avelumab by recording adverse events until 30 days after the last dose of either study treatment
Overall safety and tolerability of palbociclib with avelumab. Toxicity will be assessed by CTCAE (version 5) every 4 weeks during study treatment. Adverse events, including serious adverse events, will be recorded until 30 days after the last dose of study treatment with palbociclib or avelumab.
Measured: Total 42 month recruitment period
Assess overall survival in both parts A & B
Overall survival, calculated from day 1 of study treatment to the date of death from any cause.
Measured: Total 42 month recruitment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start11 Aug 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a two-part phase 1b trial of induction palbociclib with the addition of avelumab. In Part A of the study, the MTD of the study will be determined using a 3+3 design. There will be a 1-week interval between the first and second patients started at each dose level. In Part B, the MTD dose level will be expanded.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Breast Cancer Now
- Responsible party
- Sponsor
- Investigators
- Alicia Okines, Principal investigator, The Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360941
- Sponsor's protocol ID
- CCR4884
- Acronym
- PAveMenT
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
PubMed 11553815Sorlie T, Tibshirani R, Parker J, Hastie T, Marron JS, Nobel A, Deng S, Johnsen H, Pesich R, Geisler S, Demeter J, Perou CM, Lonning PE, Brown PO, Borresen-Dale AL, Botstein D. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8418-23. doi: 10.1073/pnas.0932692100. Epub 2003 Jun 26.
PubMed 12829800Lehmann BD, Bauer JA, Chen X, Sanders ME, Chakravarthy AB, Shyr Y, Pietenpol JA. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011 Jul;121(7):2750-67. doi: 10.1172/JCI45014.
PubMed 21633166Lehmann BD, Jovanovic B, Chen X, Estrada MV, Johnson KN, Shyr Y, Moses HL, Sanders ME, Pietenpol JA. Refinement of Triple-Negative Breast Cancer Molecular Subtypes: Implications for Neoadjuvant Chemotherapy Selection. PLoS One. 2016 Jun 16;11(6):e0157368. doi: 10.1371/journal.pone.0157368. eCollection 2016.
PubMed 27310713Wang C, Pan B, Zhu H, Zhou Y, Mao F, Lin Y, Xu Q, Sun Q. Prognostic value of androgen receptor in triple negative breast cancer: A meta-analysis. Oncotarget. 2016 Jul 19;7(29):46482-46491. doi: 10.18632/oncotarget.10208.
PubMed 27374089Tsang JY, Ni YB, Chan SK, Shao MM, Law BK, Tan PH, Tse GM. Androgen receptor expression shows distinctive significance in ER positive and negative breast cancers. Ann Surg Oncol. 2014 Jul;21(7):2218-28. doi: 10.1245/s10434-014-3629-2. Epub 2014 Mar 18.
PubMed 24639191McNamara KM, Yoda T, Nurani AM, Shibahara Y, Miki Y, Wang L, Nakamura Y, Suzuki K, Yang Y, Abe E, Hirakawa H, Suzuki T, Nemoto N, Miyashita M, Tamaki K, Ishida T, Brown KA, Ohuchi N, Sasano H. Androgenic pathways in the progression of triple-negative breast carcinoma: a comparison between aggressive and non-aggressive subtypes. Breast Cancer Res Treat. 2014 Jun;145(2):281-93. doi: 10.1007/s10549-014-2942-6. Epub 2014 Apr 9.
PubMed 24715382Pistelli M, Caramanti M, Biscotti T, Santinelli A, Pagliacci A, De Lisa M, Ballatore Z, Ridolfi F, Maccaroni E, Bracci R, Berardi R, Battelli N, Cascinu S. Androgen receptor expression in early triple-negative breast cancer: clinical significance and prognostic associations. Cancers (Basel). 2014 Jun 27;6(3):1351-62. doi: 10.3390/cancers6031351.
PubMed 24978437Luo X, Shi YX, Li ZM, Jiang WQ. Expression and clinical significance of androgen receptor in triple negative breast cancer. Chin J Cancer. 2010 Jun;29(6):585-90. doi: 10.5732/cjc.009.10673.
PubMed 20507730Asano Y, Kashiwagi S, Onoda N, Kurata K, Morisaki T, Noda S, Takashima T, Ohsawa M, Kitagawa S, Hirakawa K. Clinical verification of sensitivity to preoperative chemotherapy in cases of androgen receptor-expressing positive breast cancer. Br J Cancer. 2016 Jan 12;114(1):14-20. doi: 10.1038/bjc.2015.434.
PubMed 26757422Gucalp A, Tolaney S, Isakoff SJ, Ingle JN, Liu MC, Carey LA, Blackwell K, Rugo H, Nabell L, Forero A, Stearns V, Doane AS, Danso M, Moynahan ME, Momen LF, Gonzalez JM, Akhtar A, Giri DD, Patil S, Feigin KN, Hudis CA, Traina TA; Translational Breast Cancer Research Consortium (TBCRC 011). Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast Cancer. Clin Cancer Res. 2013 Oct 1;19(19):5505-12. doi: 10.1158/1078-0432.CCR-12-3327. Epub 2013 Aug 21.
PubMed 23965901Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26.
PubMed 29373071Bonnefoi H, Grellety T, Tredan O, Saghatchian M, Dalenc F, Mailliez A, L'Haridon T, Cottu P, Abadie-Lacourtoisie S, You B, Mousseau M, Dauba J, Del Piano F, Desmoulins I, Coussy F, Madranges N, Grenier J, Bidard FC, Proudhon C, MacGrogan G, Orsini C, Pulido M, Goncalves A. A phase II trial of abiraterone acetate plus prednisone in patients with triple-negative androgen receptor positive locally advanced or metastatic breast cancer (UCBG 12-1). Ann Oncol. 2016 May;27(5):812-8. doi: 10.1093/annonc/mdw067. Epub 2016 Feb 18.
PubMed 27052658Musgrove EA, Caldon CE, Barraclough J, Stone A, Sutherland RL. Cyclin D as a therapeutic target in cancer. Nat Rev Cancer. 2011 Jul 7;11(8):558-72. doi: 10.1038/nrc3090.
PubMed 21734724Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
PubMed 19238148