Estrogen Receptor-positive Breast CancerPhase 2NCT01368263

Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

A Phase 2 study testing goserelin acetate, letrozole and anastrozole in people with Estrogen Receptor-positive Breast Cancer and HER2-negative Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer
What is being tested?: goserelin acetate, letrozole and anastrozole
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Sep 2011to May 2013
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient must have histological or cytological confirmed invasive breast cancer
Patient must be premenopausal confirmed by serum estradiol level in the premenopausal range (> 25 pg/ml) at the beginning of the study; for women on oral contraceptives, these agents must be held for two weeks before the estradiol assessment is made
Patient must have a negative serum pregnancy test within 7 days of registration
Patient's tumor must be ER+ with or without concomitant progesterone receptor-positive (PR+) with an Allred score of 6, 7 or 8; patients with > 66.6% of cells staining positive by conventional immunohistochemistry (IHC) have a minimum Allred score of 6 and are eligible
Patient's tumors must be HER2 negative by local laboratory assessment: HER2 IHC 0, 1+, or 2+ with subsequent negative fluorescent in situ hybridization (FISH) (ratio < 1.8); negative FISH alone in absence of IHC is acceptable
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging (physical examination)

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Patient's primary tumor must be palpable and measure > 2 cm by tape, ruler or caliper measurements in at least one dimension
Patient must have mammogram and ultrasound of the breast within 42 days prior to registration; if a patient has clinically palpable or suspicious nodes, then an ultrasound of the axilla is also required
Patient, as documented by the treating physician, must be clinically staged as one of the following:
T4 a-c for which modified radical mastectomy with negative margins is the goal
T2 or T3 for which conversion from needing mastectomy to breast conservation is the goal
T2 for which lumpectomy at first attempt is the goal
Patient must be > or = 18 years old.
Patient must stop taking all forms of hormonal treatment, including oral or other form of hormonal contraceptive methods and all forms of hormone replacement therapy, at least two weeks prior to starting protocol therapy
Patient must agree to use a "highly-effective form of non-hormonal contraception" (applies to patient and/or partner)
Patient must be willing to undergo oophorectomy, if indicated
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Patient must have normal organ and marrow function as defined below:
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 3.0 X institutional upper limit of normal (ULN)
Creatinine within normal institutional limits OR
Creatinine clearance >= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
If the patient is a cancer survivor, all of the following criteria must be met
Patient has undergone potentially curative therapy from all prior malignancies
Patient must have no evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral ductal carcinoma in situ (DCIS) treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence)
Patient must be deemed by her treating physician to be at low risk (< 30%) for recurrence from prior malignancies
Patient must be able to understand and willing to sign a written informed consent document

Who cannot join

Patient must not have inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
Patient must not have had prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent; patients whose diagnosis was established by incision biopsy are not eligible
Patient must not have had prior DCIS in the ipsilateral breast
Patient must not have used tamoxifen for prior contralateral DCIS
Patient must not have any evidence of distant metastasis (M1) on imaging; staging scans are not mandatory but any exams performed as standard of care throughout the study period will be collected for correlation as needed
If patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant therapy, she is ineligible for this study

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Patient must not be receiving other investigational agents or be enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer
Pregnant and/or breastfeeding women are excluded from this study
Patient must not have any concurrent life threatening illnesses
Patient must not have undergone prior sentinel lymph node surgery; cores or FNA of lymph node are acceptable

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Multisite International Collaborative Phase 2 Study of Neoadjuvant Goserelin and a Non-steroidal Aromatase Inhibitor for Premenopausal Women With Estrogen Receptor Positive HER2 Negative Clinical Stage 2 and 3 Breast Cancer

This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy

Conditions: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Being tested: goserelin acetate, letrozole, anastrozole, chemotherapy, Surgery
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

goserelin acetateDrug
Also called ICI-118630, ZDX, Zoladex
Given SC
letrozoleDrug
Also called CGS 20267, Femara, LTZ
Given PO
anastrozoleDrug
Also called ANAS, Arimidex, ICI-D1033
Given PO
chemotherapyDrug
Also called chemo
Standard chemotherapy
SurgeryProcedure or surgery

Study groups in NCT01368263
Study group	Role	What they receive
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	Experimental	Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion. Receives: Drug: goserelin acetate; Drug: letrozole; Drug: anastrozole; Procedure: Surgery
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	Experimental	Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion. Receives: Drug: goserelin acetate; Drug: letrozole; Drug: anastrozole; Drug: chemotherapy; Procedure: Surgery
Group 3 (E2 > 15 pg/ml)	Experimental	Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion. Receives: Drug: goserelin acetate; Drug: letrozole; Drug: anastrozole; Drug: chemotherapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathologic Complete Response (CR) Rate
- In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks.
- The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Measured: 1 month
Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy
Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.
Measured: 6 months post neoadjuvant endocrine therapy and surgery

Secondary outcomes (3)

Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67
Measured: Baseline and 4 weeks post-treatment
Preoperative Endocrine Prognostic Index Score (PEPI Score)
To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Measured: At time of definitive surgery
PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011May 2013

First posted7 Jun 2011 (estimated)
Study startSep 2011
Primary completionMay 2013
Study completionMay 2013

Why it stopped: Due to funding source and lack of accrual

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 Estrogen Receptor-positive Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368263
Sponsor's protocol ID: 201106141
Status last verified: Mar 2015
First submitted: 2 Jun 2011
Last updated: 3 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Estrogen Receptor-positive Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multisite International Collaborative Phase 2 Study of Neoadjuvant Goserelin and a Non-steroidal Aromatase Inhibitor for Premenopausal Women With Estrogen Receptor Positive HER2 Negative Clinical Stage 2 and 3 Breast Cancer
ClinicalTrials.gov ID: NCT01368263
Acronym / sponsor ID: 201106141
Conditions: Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to funding source and lack of accrual
Enrolment: 8 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 20 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	Experimental	Drug: goserelin acetate, Drug: letrozole, Drug: anastrozole, Procedure: SurgeryPatients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	Experimental	Drug: goserelin acetate, Drug: letrozole, Drug: anastrozole, Drug: chemotherapy, Procedure: SurgeryPatients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Group 3 (E2 > 15 pg/ml)	Experimental	Drug: goserelin acetate, Drug: letrozole, Drug: anastrozole, Drug: chemotherapy, Procedure: SurgeryPatients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (30 listed)

Patient must have histological or cytological confirmed invasive breast cancer
Patient must be premenopausal confirmed by serum estradiol level in the premenopausal range (> 25 pg/ml) at the beginning of the study; for women on oral contraceptives, these agents must be held for two weeks before the estradiol assessment is made
Patient must have a negative serum pregnancy test within 7 days of registration
Patient's tumor must be ER+ with or without concomitant progesterone receptor-positive (PR+) with an Allred score of 6, 7 or 8; patients with > 66.6% of cells staining positive by conventional immunohistochemistry (IHC) have a minimum Allred score of 6 and are eligible
Patient's tumors must be HER2 negative by local laboratory assessment: HER2 IHC 0, 1+, or 2+ with subsequent negative fluorescent in situ hybridization (FISH) (ratio < 1.8); negative FISH alone in absence of IHC is acceptable

Key exclusion criteria (10 listed)

Patient must not have inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
Patient must not have had prior treatment for invasive breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent; patients whose diagnosis was established by incision biopsy are not eligible
Patient must not have had prior DCIS in the ipsilateral breast
Patient must not have used tamoxifen for prior contralateral DCIS
Patient must not have any evidence of distant metastasis (M1) on imaging; staging scans are not mandatory but any exams performed as standard of care throughout the study period will be collected for correlation as needed

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
goserelin acetateAlso: ICI-118630, ZDX, ZoladexGiven SC	Drug	Group 1 (Ki67 <10%, E2 <= 15 pg/ml), Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml), Group 3 (E2 > 15 pg/ml)
letrozoleAlso: CGS 20267, Femara, LTZGiven PO	Drug	Group 1 (Ki67 <10%, E2 <= 15 pg/ml), Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml), Group 3 (E2 > 15 pg/ml)
anastrozoleAlso: ANAS, Arimidex, ICI-D1033Given PO	Drug	Group 1 (Ki67 <10%, E2 <= 15 pg/ml), Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml), Group 3 (E2 > 15 pg/ml)
chemotherapyAlso: chemoStandard chemotherapy	Drug	Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml), Group 3 (E2 > 15 pg/ml)
Surgery	Procedure or surgery	Group 1 (Ki67 <10%, E2 <= 15 pg/ml), Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml), Group 3 (E2 > 15 pg/ml)

Primary outcome

Pathologic Complete Response (CR) Rate
Time frame: 1 month
* In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy
Time frame: 6 months post neoadjuvant endocrine therapy and surgery
Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.

3 secondary outcomes

Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67
Time frame: Baseline and 4 weeks post-treatment
Preoperative Endocrine Prognostic Index Score (PEPI Score)
Time frame: At time of definitive surgery
PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less
Time frame: 16 weeks

Results and safety

Results posted to the registry on 20 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	6	6
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	1	1
Group 3 (E2 > 15 pg/ml)	1	1

Primary outcome: Pathologic Complete Response (CR) Rate

Time frame: 1 month

Population analysed: There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 \>10% and estradiol levels of \<= 15 pg/ml at 4 weeks.

Primary outcome: Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy

Time frame: 6 months post neoadjuvant endocrine therapy and surgery

Population analysed: None of the participants had a PEPI score and 0 and pathological stage 1.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)	0 of 6 (0%)	6 of 6 (100%)	Not reported
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)	0 of 1 (0%)	1 of 1 (100%)	Not reported
Group 3 (E2 > 15 pg/ml)	0 of 1 (0%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.

Related trials for Estrogen Receptor-positive Breast Cancer

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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.

Timothy Pluard, M.D. principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 30 inclusion and 10 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 3 Apr 2015. 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 20 Feb 2015). 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?

Pathologic Complete Response (CR) Rate (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368263.

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 3 Apr 2015.