Metastatic Breast CancerPhase 2NCT02000596
1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
A Phase 2 study testing Trastuzumab plus Pertuzumab, Hormonal Therapy with Anastrozole and Fulvestrant and Chemotherapy with Eribulin in people with Metastatic Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Trastuzumab plus Pertuzumab, Hormonal Therapy with Anastrozole and Fulvestrant and Chemotherapy with Eribulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥60 Years of Age.
- Histologically confirmed, locally advanced (T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that progressed after treatment with standard treatment regimens in the adjuvant or neoadjuvant setting.
- Prior treatment with trastuzumab and/or lapatinib in the neo-adjuvant or adjuvant setting is allowed but not required. Lapatininb has to be discontinued > 21 days before the initiation of the T+P study treatments.
- Up to 3 prior chemo regimens for treatment of metastatic disease are allowed as long as the study subject is acceptable for study treatment with chemo required on this study in cohort 2 at progression on T+P.
- Patients may have had prior hormonal therapy with any hormonal agents as per section 3.1.5 of this protocol.
- Zometa or denosumab can be continued as per standard of care as long as started before the study treatment is started.
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- HER2 positive breast cancer, as defined in Section 3.3 of this protocol
- Must have measurable or evaluable disease according to RECIST 1.1 criteria.
- Lab values obtained ≤7 days prior to registration as indicated in 3.1.9 of this protocol.
- ECOG Performance Status (PS) of 0, 1 or 2.
- LVEF at least 50% as determined by MUGA or ECHO.
- Life expectancy >3 months.
- Written informed consent.
- Willingness to return to study site for treatment and follow-up.
- Normal QTc interval defined on EKG as QTc ≤ 440 msec.
- Postmenopausal women defined in section 3.1.16 of this protocol.
Who cannot join
- Stage III or IV cancer, other than breast cancer, in ≤5 years prior to registration.
- Actively being treated for other malignancy.
- New York Heart Association Class III or IV cardiovascular disease.
- History of coronary heart failure (CHF)
- Current use of drugs known to prolong the QTc interval including Class Ia and III antiarrhythmics or history of congenital long QTc syndrome.
- Evidence of active brain metastasis including leptomeningeal involvement.
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- Major surgery, chemotherapy, hormonal or immunologic therapy ≤3 weeks prior to registration.
- Radiotherapy ≤3 weeks prior to registration, except if to a non-target lesion only.
- Prior treatment with Pertuzumab, Eribulin, Fulvestrant or Anastrozole.
- Uncontrolled illness.
- Co-morbid systemic illnesses or other severe concurrent disease. See section 3.2.11.
- Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
- International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 × ULN (unless on anticoagulation medication)
- Receipt of intravenous (IV) antibiotics for infection within 7 days prior to enrollment into the study.
- Current chronic daily treatment with corticosteroids. See section 3.2.16 of this protocol.
- Known hypersensitivity to any of the study treatments or to excipients of recombinant human or humanized antibodies.
- History of receiving any investigational treatment within 28 days prior to enrollment into the study.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
About this study
Official title: 1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.
Read the detailed description
Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC) include treatments with chemotherapy or hormonal therapy, alone or in combination with medications that target HER2 gene, such as Trastuzumab or Pertuzumab. This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab, without hormonal or chemotherapy, as a first line treatment. If patients progress on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment. The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Trastuzumab plus Pertuzumab, Hormonal Therapy with Anastrozole and Fulvestrant, Chemotherapy with Eribulin
- Keywords
- HER2 overexpressed, Metastatic Breast Cancer, Elderly
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab plus PertuzumabDrug
Hormonal Therapy with Anastrozole and FulvestrantDrug
Also called Anastrozole (Arimidex), Fulvestrant (Faslodex)
Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
Chemotherapy with EribulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: T+P | Experimental | Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy) Receives: Drug: Trastuzumab plus Pertuzumab |
| Cohort 2 - Arm A | Experimental | Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR + Receives: Drug: Trastuzumab plus Pertuzumab; Drug: Hormonal Therapy with Anastrozole and Fulvestrant |
| Cohort 2 - Arm B | Experimental | Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR - Receives: Drug: Trastuzumab plus Pertuzumab; Drug: Chemotherapy with Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) in Patients
Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as >= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) >= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
Measured: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
Secondary outcomes (4)
Progression-free Survival (PFS)
Progression Free Survival in treatment cohorts 1 and 2 as well as arms A and B from the time on study until progression of disease or death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
Overall Survival (OS)
Overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B from the time on study until death
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients
Measured: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months
Quality of Life Via Patient-reported Outcomes
quality of life and treatment side effects via patient-reported and investigator reported outcomes
Measured: Duration of study, participants were followed every cycle up to 11 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionJan 2016
Why it stopped: funding withdrawn by sponsor
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.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Katherine Tkaczuk, MD, Principal investigator, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000596
- Sponsor's protocol ID
- HP-00054959; 1303GCC
- Other IDs
- GCC1303
- Status last verified
- May 2022
- First submitted
- 21 Nov 2013
- Last updated
- 27 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma
- ClinicalTrials.gov ID
- NCT02000596
- Acronym / sponsor ID
- HP-00054959; 1303GCC
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER2 overexpressed, Metastatic Breast Cancer, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding withdrawn by sponsor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 27 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.
Detailed description
Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC) include treatments with chemotherapy or hormonal therapy, alone or in combination with medications that target HER2 gene, such as Trastuzumab or Pertuzumab. This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab, without hormonal or chemotherapy, as a first line treatment. If patients progress on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment. The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: T+P | Experimental | Drug: Trastuzumab plus PertuzumabTrastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy) |
| Cohort 2 - Arm A | Experimental | Drug: Trastuzumab plus Pertuzumab, Drug: Hormonal Therapy with Anastrozole and FulvestrantHormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR + |
| Cohort 2 - Arm B | Experimental | Drug: Trastuzumab plus Pertuzumab, Drug: Chemotherapy with EribulinChemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR - |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women ≥60 Years of Age.
- Histologically confirmed, locally advanced (T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that progressed after treatment with standard treatment regimens in the adjuvant or neoadjuvant setting.
- Prior treatment with trastuzumab and/or lapatinib in the neo-adjuvant or adjuvant setting is allowed but not required. Lapatininb has to be discontinued > 21 days before the initiation of the T+P study treatments.
- Up to 3 prior chemo regimens for treatment of metastatic disease are allowed as long as the study subject is acceptable for study treatment with chemo required on this study in cohort 2 at progression on T+P.
- Patients may have had prior hormonal therapy with any hormonal agents as per section 3.1.5 of this protocol.
Key exclusion criteria (19 listed)
- Stage III or IV cancer, other than breast cancer, in ≤5 years prior to registration.
- Actively being treated for other malignancy.
- New York Heart Association Class III or IV cardiovascular disease.
- History of coronary heart failure (CHF)
- Current use of drugs known to prolong the QTc interval including Class Ia and III antiarrhythmics or history of congenital long QTc syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab plus Pertuzumab | Drug | Cohort 1: T+P, Cohort 2 - Arm A, Cohort 2 - Arm B |
| Hormonal Therapy with Anastrozole and FulvestrantAlso: Anastrozole (Arimidex), Fulvestrant (Faslodex)Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days | Drug | Cohort 2 - Arm A |
| Chemotherapy with Eribulin | Drug | Cohort 2 - Arm B |
Primary outcome
Overall Response Rate (ORR) in Patients
Time frame: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as >= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) >= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months
Quality of Life Via Patient-reported Outcomes
Time frame: Duration of study, participants were followed every cycle up to 11 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Tkaczuk, MD principal investigator
University of Maryland Greenebaum Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab plus Pertuzumab, Hormonal Therapy with Anastrozole and Fulvestrant and Chemotherapy with Eribulin in people with Metastatic Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) in Patients (time frame: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.