Breast CancerPhase 2TOUCHNCT03644186
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
A Phase 2 study testing Paclitaxel, Trastuzumab and Pertuzumab in people with Breast Cancer and Estrogen Receptor Positive Tumor, run by ETOP IBCSG Partners Foundation at 54 sites in 4 countries.
Trial summary
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- What is being tested?
- Paclitaxel, Trastuzumab and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 54 sitesin 4 countries
- Study dates
- 16 Apr 2019to 14 Apr 2023
- Phase
- Phase 2
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer, with the following characteristics:
- Early breast cancer with tumor size >1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography);
- No clinical evidence of regional lymph node metastasis (via physical and/or radiological exam) (cN0) OR
- Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s)
- No evidence of metastasis (M0).
- Postmenopausal, defined by women with:
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- Prior bilateral surgical oophorectomy; OR
- Amenorrhea and age ≥60 years; OR
- Age <60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, ovarian suppression, or hormonally-based contraception) plus FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Primary tumor must have positive estrogen receptor (ER) ≥10%
- Primary tumor must be HER2-positive (by IHC and/or ISH)
- Baseline LVEF ≥55% measured by Echocardiography (preferred) or MUGA scan
- Normal hematologic status:
- Absolute neutrophil count ≥1500/mm3 (1.5 × 109/L);
- Platelets ≥100 × 109/L;
- Hemoglobin ≥9 g/dL (≥90 g/L).
- Normal renal function: serum creatinine ≤1.5 ULN
- Normal liver function:
- Serum total bilirubin ≤1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 × ULN) is allowed;
- AST or ALT ≤2.5 × ULN;
- Alkaline phosphatase ≤2.5 × ULN.
- Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
- The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
- The patient agrees in writing to make tumor (mandatory diagnostic core biopsy and surgical specimen) available for submission for central pathology review and to conduct translational studies as part of this protocol.
Who cannot join
- Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) (T4 according to AJCC 8th edition cancer staging TNM)
- Inflammatory breast cancer
- Bilateral invasive breast cancer
- Received any prior treatment for primary invasive breast cancer
- Any active tumor of non-breast-cancer histology
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification ≥II), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
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- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
- Contraindications or known hypersensitivity to any of the trial medications or excipients
- Treatment with any investigational agents within 30 days prior to expected start of trial treatment
- Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection
- Evidence via physical and/or radiological exam of cN2 or cN3 nodal involvement defined by: metastasis to ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted, OR involvement of ipsilateral infraclavicular, internal mammary and/or supraclavicular lymph node(s)
- History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
Italy22 sites
ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16
Alessandria, Alessandria, 15121
Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2
Aviano, Pordenone, 33081
Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1
Bergamo, Bergamo, 24127
Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2
Bologna, Bologna, 40138
Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5
Bolzano, Bolzano, 39100
ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1
Brescia, Brescia, 25123
U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2
Carpi, Modena, 41012
E.O. Ospedali Galliera, Mura delle Cappuccine, 14
Genova, Genova, 16128
Ospedale Policlinico San Martino,Largo Rosanna Benzi,10
Genova, Genova, 16132
Ospedale Civile di Lecco,Via della Filanda 14
Lecco, Lecco, 23900
Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40
Meldola, Forli, 47014
Milano, IEO, Via Ripamonti 435
Milan, Milano, 20141
Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18
Novara, Novara, 28100
Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14
Parma, Parma, 43126
Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10
Pavia, Pavia, 27100
A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67
Pisa, Pisa, 56125
Hospital of Prato, Via Dolce dei Mazzamuti, 7
Prato, Prato, 59100
Santa Maria delle Croci Hospital, Viale Randi 5
Ravenna, Ravenna, 48121
UO Oncologia, Rimini Hospital, Via Settembrini 2
Rimini, Rimini, 47037
Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,
Torrette, Ancona, 60020
Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15
Udine, Udine, 33100
AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57
Varese, Varese, 21100
France15 sites
Institut Sainte Catherine
Avignon
Institut Bergonié
Bordeaux
Centre Hospitalier Le Mans
Le Mans
Centre Léon Berard
Lyon
ICM Val d'Aurelle
Montpellier
Institut de Cancérologie de l'Ouest (ICO)
Nantes
Centre Antoine Lacassagne
Nice
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Institut Curie - Site de Paris
Paris
Centre Hospitalier Annecy Genevois
Pringy
Centre Eugène Marquis
Rennes
Centre Henri Becquerel
Rouen
Institut Curie - Site Saint Cloud
Saint-Cloud, 92210
Clinique Pasteur
Toulouse
Institut Claudius Regaud
Toulouse
Switzerland11 sites
Kantonsspital Baden AG
Baden, Aarau, 5400
Universitatsspital Basel, Petersgraben 4
Basel, Canton of Basel-City, 4031
Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI
Bellinzona, Canton Ticino, 6500
Inselspital Bern
Bern
Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4
Frauenfeld, Thurgau, 8501
HFR Freiburg - Kantonsspital
Fribourg, 1708
University Hospital Geneva
Geneva
Kantonsspital St. Gallen, Rorschacher Strasse 95
Sankt Gallen, Canton of St. Gallen, 9007
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Brust-Zentrum AG, Seefeldstrasse 214
Zurich, Canton of Zurich, 8008
University Hospital Zurich, Frauenklinikstrasse 10
Zurich, Canton of Zurich, 8091
Belgium6 sites
AZ Klina, Augustijinslei 100
Brasschaat, 2930
Jules Bordet Institute
Brussels, 1000
CHR de la Citadelle, Boulevard du XIIe de Ligne, 1
Liège, 4000
Clinique Saint- Joseph, Rue de Hesbaye 75
Liège, 4000
Clinique Saint Elizabeth, Place Louise Godin 15
Namur, 5000
AZ Nikolaas, Moerlandstrat 1
Sint-Niklaas, 9100
About this study
Official title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.
Read the detailed description
TOUCH is an open label, international, phase II neoadjuvant trial which will assess the treatment of elderly patients with hormone receptor positive / human epidermal growth factor receptor-2 (HER2) positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.
The neo-adjuvant setting was chosen to evaluate these therapy combinations in a short time-frame and to provide access to biomaterial both at baseline and after the end of the treatment, at surgery. Biopsy specimens will be analyzed at the end of the trial by gene-expression profiling to assess RBsig status. This marker may represent a tool to identify the participants who are more likely to benefit from a chemotherapy-free regimen in this population.
Palbociclib is a potent, highly selective, reversible, orally active, inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4/6), therefore inhibiting cell growth and can be safely and effectively administered to older patients without need for dose adjustment based solely on age. Treatment de-escalation, namely harnessing and taking maximum advantage of targeted therapies vs conventional treatment (chemotherapy) in order to limit side effects, is particularly appealing in the older population.
Clinical data from the HR positive /HER2 negative setting show that combinations of palbociclib and letrozole are safe and effective. These combinations have not yet been tested in the HR positive /HER2 positive population that the investigators include in this trial. However, combinations of trastuzumab and endocrine treatment (ET), including letrozole have shown to be safe and to have some additional activity compared to ET alone in the HR positive /HER2 positive population. Therefore, the role of palbociclib in addition to letrozole and trastuzumab plus pertuzumab needs to be further studied.
Current standard of care for treatment of HER2 positive BC incorporates chemotherapy and anti-HER2 agents, with chemotherapy regimens of sequential anthracyclines and taxanes, used as single agents or in combination with other chemotherapy drugs. Trastuzumab is often administered concurrently with a single agent taxane to avoid the possible additive cardiac toxicity of combinations of anthracycline containing regimens and trastuzumab.
A regimen of weekly paclitaxel and trastuzumab plus pertuzumab was chosen as the comparator arm in this trial. More aggressive chemotherapy may not be justified in this population and trial participants may receive additional treatment after surgery, at the discretion of the treating doctor.
Preclinical and clinical rationale exists to support the proposal that palbociclib may represent a valuable option for increasing the activity of ET and anti-HER2 agents, such that a triple combination with these agents could prove superior to a standard treatment with chemotherapy and anti-HER2 agents.
The investigators hypothesize that the combination of palbociclib, letrozole and trastuzumab plus pertuzumab proposed in this trial will be more efficacious compared to the combinations of anti-HER2 agents and ET reported in other trials.
In 2019, it is estimated that of 260,600 newly diagnosed cases of invasive breast cancer in the United States, 82% occurred in women aged 50 or over. Furthermore, of the 41,760 breast cancer-related deaths in the same year, 90% occurred in this predominantly post-menopausal age group. Around 40% of BCs occur in women aged 65 and older. Of these, 10-15% have tumors that overexpress HER2. Elderly patients are generally underrepresented in clinical trials and may benefit from anti-HER2 agents as much as the younger population. Post-menopausal patients with HR positive /HER2 positive BC represent a unique group of patients with an unmet clinical need. This population is the focus of the TOUCH trial.
- Being tested
- Paclitaxel, Trastuzumab, Pertuzumab, Palbociclib, Letrozole
- Keywords
- hormone receptor positive early breast cancer, HER2 receptor positive early breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Paclitaxel Sandoz
Chemotherapy plus HER2 Blockade
TrastuzumabDrug
Also called Herceptin
Chemotherapy plus HER2 Blockade
PertuzumabDrug
Also called Perjeta
Chemotherapy plus HER2 Blockade
PalbociclibDrug
Also called Ibrance
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
LetrozoleDrug
Also called Femara
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
TrastuzumabDrug
Also called Herceptin
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
PertuzumabDrug
Also called Perjeta
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel plus trastuzumab and pertuzumab | Active comparator | Receiving paclitaxel 80mg/m2 i.v. on day 1, 8, 15 every 28 days for 4 cycles, trastuzumab 600mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for a total of 5 doses. Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab |
| Palbociclib plus letrozole plus trastuzumab and pertuzumab | Experimental | Receiving palbociclib 125 mg/day orally for 21 days followed by 7 day's rest, for four 28 day cycles, letrozole 2.5 mg/day orally for 16 weeks and trastuzumab 600 mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for 5 doses. Receives: Drug: Palbociclib; Drug: Letrozole; Drug: Trastuzumab; Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Pathological complete response (pCR) is defined as absence of invasive tumour cells in the breast and in the axillary lymph nodes at the time of surgery (ypT0/ypTis ypN0) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual. The presence of in situ cancer after trial treatment in the absence of residual invasive disease constitutes a pCR.
Measured: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Secondary outcomes (3)
Pathological Complete Response (pCR) in the Breast
Defined as the absence of invasive tumour cells in the breast at the time of surgery (ypT0/ypTis) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual..
Measured: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.
Objective Response
The number of patients with partial or complete response measured physically by caliper and by ultrasound and mammography. Response was assessed using World Health Organization tumor measurement and response criteria.
Complete response (CR) - The disappearance of all known disease. Partial response (PR) - A 50% or more decrease in total tumor size, i.e., the sum of the products of the maximal diameter (MD) and the corresponding largest perpendicular diameter (LPD) of the lesions which have been measured to determine the effect of therapy. In addition, there can be no appearance of new lesions or progression of any lesion.
Stable disease (SD) - Neither a 50% decrease in total tumor size, nor a 25% increase in the size of one or more measurable lesions has been determined.
Progressive disease (PD) - An increase of least 25% in total tumor size relative to the smallest size measured during the trial.
Measured: Tumor assessments were performed by ultrasound and mammography at screening (prior to treatment start), and before surgery; measurements by caliper were assessed at the same time points and at the end of cycle 2 (28 days/cycle), approximately 56 days.
Rate of Breast Conserving Surgery (BCS)
Defined as the number of patients undergoing BCS, divided by the number of patients in the assessable population (subset of the randomized population with RBsig status successfully determined who received at least 1 dose of medication).
Measured: From randomization until completion of study, up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start16 Apr 2019
- Primary completion3 Jan 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Collaborators
- Pfizer, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Laura Biganzoli, MD, Study chair, USL4 Hospital of Prato, ItalyEtienne Brain, MD, Study chair, Institut Curie, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644186
- Sponsor's protocol ID
- IBCSG 55-17
- Other IDs
- 2017-005067-40, 2017
- Acronym
- TOUCH
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2018
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biganzoli L, Wildiers H, Oakman C, Marotti L, Loibl S, Kunkler I, Reed M, Ciatto S, Voogd AC, Brain E, Cutuli B, Terret C, Gosney M, Aapro M, Audisio R. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol. 2012 Apr;13(4):e148-60. doi: 10.1016/S1470-2045(11)70383-7. Epub 2012 Mar 30.
PubMed 22469125Biganzoli L, Aapro M, Loibl S, Wildiers H, Brain E. Taxanes in the treatment of breast cancer: Have we better defined their role in older patients? A position paper from a SIOG Task Force. Cancer Treat Rev. 2016 Feb;43:19-26. doi: 10.1016/j.ctrv.2015.11.009. Epub 2015 Dec 15.
PubMed 26827689Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.
PubMed 23000897Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.
PubMed 26947331Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46. doi: 10.1002/sim.2980.
PubMed 17634969Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.
PubMed 19874578Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
PubMed 27959613Herschkowitz JI, He X, Fan C, Perou CM. The functional loss of the retinoblastoma tumour suppressor is a common event in basal-like and luminal B breast carcinomas. Breast Cancer Res. 2008;10(5):R75. doi: 10.1186/bcr2142. Epub 2008 Sep 9.
PubMed 18782450Jenkins EO, Deal AM, Anders CK, Prat A, Perou CM, Carey LA, Muss HB. Age-specific changes in intrinsic breast cancer subtypes: a focus on older women. Oncologist. 2014 Oct;19(10):1076-83. doi: 10.1634/theoncologist.2014-0184. Epub 2014 Aug 20.
PubMed 25142841Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.
PubMed 19786658Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Revil C, Jones A. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009 Nov 20;27(33):5529-37. doi: 10.1200/JCO.2008.20.6847. Epub 2009 Sep 28.
PubMed 19786670Malorni L, Piazza S, Ciani Y, Guarducci C, Bonechi M, Biagioni C, Hart CD, Verardo R, Di Leo A, Migliaccio I. A gene expression signature of retinoblastoma loss-of-function is a predictive biomarker of resistance to palbociclib in breast cancer cell lines and is prognostic in patients with ER positive early breast cancer. Oncotarget. 2016 Sep 13;7(42):68012-68022. doi: 10.18632/oncotarget.12010.
PubMed 27634906Miles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.
PubMed 24129974Witkiewicz AK, Ertel A, McFalls J, Valsecchi ME, Schwartz G, Knudsen ES. RB-pathway disruption is associated with improved response to neoadjuvant chemotherapy in breast cancer. Clin Cancer Res. 2012 Sep 15;18(18):5110-22. doi: 10.1158/1078-0432.CCR-12-0903. Epub 2012 Jul 18.
PubMed 22811582